CO-IMPACT: Caring Others Increasing EngageMent in PACT

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT02328326

Collaborator

(none)

478

Enrollment

Locations

Arms

42.6

Actual Duration (Months)

239

Patients Per Site

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial will compare two methods of increasing engagement in care and success in diabetes management, among patients with diabetes with high-risk features, who also have family members involved in their care.

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Other: CO-IMPACT Other: PACT	N/A

Detailed Description

Background:

Veterans with diabetes must control cardiovascular risk factors in order to prevent disabling and life-threatening complications. However, despite system wide advances in diabetes quality of care, over 30% of VHA patients with diabetes continue to have uncontrolled blood pressure, hyperglycemia, or hyperlipidemia. The nationwide VA PACT (Patient-Aligned Care Teams) initiative seeks to provide patients comprehensive, team-based support for following diabetes care regimens. PACT's success, however, hinges on its ability to effectively engage patients in care. One relatively untapped resource for supporting engagement in PACT is patients' family and friends. Three out of four adults with diabetes reach out to an unpaid family member or friend (a 'Care Partner') for ongoing help with diabetes management. These supporters help patients with medication adherence, tracking home glucose measurements, maintaining a healthy eating plan, and often accompany patients to their medical visits. However, while PACT emphasizes the importance of family members as part of the care team, PACT does not have formal mechanisms to involve health supporters in PACT care. Health supporters report that, in order to be more effective, they need more information on patient's medical care plans, clear channels for communicating with PACT team members, and information on navigating PACT resources.

Objectives:

The overall objective of this randomized trial is to test a strategy to strengthen the capacity of supporters to help patients with high-risk diabetes engage in PACT care and successfully enact care plans.

The central hypothesis is that providing health care engagement tools to both Care Partners and patients will increase patient activation and improve management of diabetes complication risks.

Methods:

This is a randomized controlled trial evaluating an intervention (Caring Others Increasing EngageMent in PACT, or CO-IMPACT) designed to structure and facilitate health supporter involvement in PACT so that patients can become more actively engaged in PACT care. 240 patients with diabetes receiving PACT primary care who: 1) are at high risk for diabetes complications due to hyperglycemia OR high blood pressure and 2) have a health supporter involved in their care will be recruited along with their health supporter. Patient-supporter dyads are randomized to the CO-IMPACT intervention or usual PACT care for high-risk diabetes, for 12 months.

The intervention provides patient-supporter dyads: one coaching session on action planning, communicating with providers, navigation skills and support skills; preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns. CO-IMPACT builds on medical record-integrated patient activation tools in the PACT toolkit and is designed to be implementable within existing PACT nurse encounters.

Primary outcomes for this study include a validated measure of patient activation (Patient Activation Measure-13) and a cardiac event 5-year risk score designed for patients with diabetes (UKPDS Risk Engine). Secondary outcomes include patients' self-efficacy for diabetes self-care; diabetes self-management behaviors including medication adherence; diabetes distress; and glycemic and blood pressure control. Measures among supporters include supporter activation, use of effective support techniques, distress about patient's diabetes care, and caregiver burden. We are also measuring patient-supporter and patient-provider relationship quality, patient safety (e.g. hypoglycemia), utilization, potential moderators of intervention effect such as patient health literacy level, and facilitators and barriers to wider implementation.

Study Design

Study Type:

Interventional

Actual Enrollment :

478 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

Engaging Veterans and Family Supporters in PACT to Improve Diabetes Management

Actual Study Start Date :

Nov 16, 2016

Actual Primary Completion Date :

Jun 6, 2019

Actual Study Completion Date :

Jun 6, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CO-IMPACT patient and supporter (dyad) receive one coaching session on action planning, communicating with providers, navigation skills and support skills; preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns	Other: CO-IMPACT Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter
Active Comparator: PACT patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits	Other: PACT participants will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits

Arm

Intervention/Treatment

Experimental: CO-IMPACT

patient and supporter (dyad) receive one coaching session on action planning, communicating with providers, navigation skills and support skills; preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns

Other: CO-IMPACT

Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter

Active Comparator: PACT

patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits

Other: PACT

participants will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits

Outcome Measures

Primary Outcome Measures

Change in Patient Activation, as Measured by Patient Activation Measure - 13 [Baseline to 12 months]
Patient Activation Measure-13. Range of potential values (0,100), higher scores mean a better outcome, Outcome is the participant's difference in the measure between baseline and 12 months, among patient participants
Change in Cardiac Event 5-year Risk Score, as Measured by UKPDS Risk Engine [Baseline to 12 months]
UKPDS Risk Engine, among patient participants only, range is 0 to 100% risk of cardiac event over the next 5 years. Lower score equals a better outcome. Outcome is the participant's difference in the measure between baseline and 12 months.

Secondary Outcome Measures

Change in Diabetes Self-Management Behavior - Healthy Eating [Baseline to 12 months]
Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values for healthy eating subscale (0 - 7 days per week), higher scores mean better outcomes, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Change in Glycemic Control [Baseline to 12 months]
Hemoglobin A1c, among patient participants. Common range is 4% to 14%, lower values indicate better outcomes. Outcome is the participant's difference in the measure between baseline and 12 months.
Change in Systolic Blood Pressure [Baseline to 12 months]
mmHg, Average of two readings done at each time point. Common physiologic range is 80mmHg - 220mmHg. Lower values indicate better outcomes, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Change in Diabetes Distress [Baseline to 12 months]
Problem Areas in Diabetes Scale (PAID) - range of potential values (0,20), higher scores indicate worse outcomes (greater diabetes-related emotional distress), among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Change in Activation in Health Encounters [Baseline to 12 months]
Perceived Efficacy in Patient-Physician Interactions (PEPPI-5) - range of potential values (5, 25), higher scores indicate better outcomes (higher perceived self-efficacy in patient-physician interactions), among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Change in Non-Fasting Lipid Levels [Baseline to 12 months]
Total cholesterol mg/DL to HDL mg/DL Ratio, common range is 1-10, lower values indicate better outcomes, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Change in Patient Satisfaction With Healthcare System Support for Family Supporter [Baseline to 12 months]
Measured as percent of patient participants answering they were 'very satisfied' or 'satisfied' with healthcare system support for their Care Partner (family supporter)'s participation in their healthcare. Response options were 'very unsatisfied', 'unsatisfied', 'neither', 'satisfied', or 'very satisfied'. Increase in proportion of 'very satisfied' or 'satisfied' indicates better outcomes (higher satisfaction), among patient participants.
Change in Supporter Use of Autonomy-Supportive Communication [Baseline to 12 months]
Important Other Climate Questionnaire (IOCQ) - patient rating of supporter communication. Range of potential values (1,7), higher scores indicate better outcomes (higher patient perception of supporter use of autonomy supportive communication), among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Change in Smoking Status [Baseline to 12 months]
Global Adult Tobacco Survey, values include 'current smoker', 'former smoker', or 'never smoker'. Change from current to former smoker over 12 months indicates a better outcome. Measured among patient participants.
Change in Diabetes Self-Management Behavior - Physical Activity [Baseline to 12 months]
Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values for physical activity subscale (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Change in Diabetes Self-Management Behavior - Blood Sugar Home Testing [Baseline to 12 months]
Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Change in Diabetes Self-Management Behavior - Blood Pressure Home Testing [Baseline to 12 months]
Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Change in Diabetes Self-Management Behavior - Take Oral Meds as Prescribed [Baseline to 12 months]
Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Change in Diabetes Self-Management Behavior - Take Insulin as Prescribed [Baseline to 12 months]
Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Change in Diabetes Self-Management Behavior - Check Feet [Baseline to 12 months]
Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.

Other Outcome Measures

Change in Diabetes Self-Efficacy [Baseline to 12 months]
Adapted Stanford Chronic Disease self-efficacy scale, among patient participants. Range of potential values (1,10), higher score indicates higher self-efficacy. Outcome is the participant's difference in the measure between baseline and 12 months.
Change in Supporter Self-Efficacy for Helping With Diabetes Care [Baseline to 12 months]
Adapted Stanford Chronic Disease self-efficacy scale, among family supporter participants. Range of potential values (1,10), higher score indicates higher self-efficacy. Outcome is the participant's difference in the measure between baseline and 12 months.
Change in Caregiver Burden [Baseline to 12 months]
Caregiver Strain Index - range of potential values (0,13), higher scores (7 or more) mean worse outcomes, among family supporter participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Change in Supporter Distress About Patient Participant's Diabetes [Baseline to 12 months]
Adapted Problem Areas In Diabetes Scale (PAID) - range of potential values (0,20), higher scores indicate worse outcomes (greater diabetes-related emotional distress), among family supporter participants. Outcome is the participant's difference in the measure between baseline and 12 months.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient Inclusion Criteria:

Provide signed and dated informed consent form
Plan to be be available for the duration of the study
Male or female, age 30-70 years old
Plan to get most diabetes care at recruiting VA primary care clinic over the subsequent 12 months
Able to use telephone to respond to bi-weekly automated Interactive Voice Response (IVR) calls
Be able to identify an adult family member or friend who is regularly involved in their health management or health care (involved with medications, managing sugars, coming to appointments, etc)
Have a diagnosis of diabetes and be at high-risk for diabetes complications, defined as: (1) a diagnosis of diabetes based on encounter diagnoses from 1 inpatient or 2 outpatient encounters (OR a diabetes medication (at least one >3 month prescription from VA drug classes HS501 (insulin) or HS502, other than metformin), (2) have an assigned VAprimary care provider and at least 2 visits to VA primary care in the previous 12 months, (3) poor glycemic control (last HbA1C within 9 months >8%) OR poor blood pressure control (last BP 160/100 or mean 6 month BP >150/90)

Care Partner Inclusion Criteria:

21 years old or older
Fluent in English
Live in the United States

Exclusion Criteria:

Patient Exclusion Criteria:

Expect to have >1 month gap in VA care in the 12 months following enrollment (e.g. snowbird travel).
Plan to receive the majority of their care for diabetes mainly from a non-Primary Care provider in the 12 months following enrollment
Have a VA resident/trainee as their main primary care provider
Live in a nursing home OR assisted living
Have significant cognitive impairment as measured by an Electronic Medical Record (EMR) diagnosis of Alzheimer's disease or dementia, or a score of <4 on the Callahan screener to identify cognitive impairment
Need help with more than two basic activities of daily living (ADLs) as measured by the Katz Basic Activities of Daily Living Scale
Do not speak English
Have a life-limiting severe illness (such as stage renal disease [ESRD] requiring dialysis, chronic obstructive pulmonary disease (COPD) requiring oxygen, cancer undergoing active treatment, receiving palliative/hospice care)
Are concurrently enrolled in another research study or clinical program, at time of enrollment, that could conflict with the current study's protocol (e.g. another diabetes management research intervention, or VA tele-buddy program involving frequent phone calls)
Do not have a working phone or are not able to use a telephone to respond to automated IVR calls
Currently Pregnant or planning to become pregnant at time of enrollment
Have a serious mental illness or active substance abuse issue

Care Partner Exclusion Criteria:

Receive pay for caring for the patient
talks with patient about health less than two times per month
Have significant cognitive impairment as measured by a score of 4 or less <4 on the Callahan screener to identify cognitive impairment
Need help with more than two basic ADL as measured by the Katz Basic Activities of Daily Living Scale
Have a life-limiting severe illness (such as end-stage renal disease requiring dialysis, chronic lung disease requiring oxygen, cancer undergoing active treatment, receiving palliative/hospice care)
Ever told by a doctor they have dementia, schizophrenia, or manic depression

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan	United States	48105
2	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Pittsburgh	Pennsylvania	United States	15240

Sponsors and Collaborators

VA Office of Research and Development

Investigators

Principal Investigator: Ann-Marie Rosland, MD MS, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - Sep 8, 2017

More Information

Publications

Rosland AM, Piette JD, Trivedi R, Kerr EA, Stoll S, Tremblay A, Heisler M. Engaging family supporters of adult patients with diabetes to improve clinical and patient-centered outcomes: study protocol for a randomized controlled trial. Trials. 2018 Jul 24;19(1):394. doi: 10.1186/s13063-018-2785-2.

Responsible Party:

VA Office of Research and Development

ClinicalTrials.gov Identifier:

NCT02328326

Other Study ID Numbers:

IIR 14-074

First Posted:

Dec 31, 2014

Last Update Posted:

Oct 6, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by VA Office of Research and Development

Diabetes

diabetes self-management

patient activation

social support

Additional relevant MeSH terms:

Diabetes Mellitus

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 11/16/16 to 5/22/18. Eligible patient participants were identified from one of two participating VHA sites. Once identified, they received an introductory letter about the study and indicated interest by phone or mail.
Pre-assignment Detail	None. All patient-supporter dyads who enrolled in the study were randomized to one of two study arms.

Arm/Group Title	CO-IMPACT	PACT
Arm/Group Description	patient and supporter (dyad) receive one coaching session on action planning, communicating with providers, navigation skills and support skills; preparation by phone before patients? primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter	patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits PACT: participants will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits
Period Title: Overall Study
STARTED	246	232
6-month Follow Up	221	221
COMPLETED	224	224
NOT COMPLETED	22	8

Baseline Characteristics

Arm/Group Title	CO-IMPACT	PACT	Total
Arm/Group Description	patient and supporter (dyad) receive one coaching session on action planning, communicating with providers, navigation skills and support skills; preparation by phone before patients? primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter	patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits PACT: participants will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits	Total of all reporting groups
Overall Participants	246	232	478
Age (years) [Median (Inter-Quartile Range) ]
Patient Participants	62	64	64
Sex: Female, Male (Count of Participants)
Female	6 2.4%	2 0.9%	8 1.7%
Male	117 47.6%	114 49.1%	231 48.3%
Female	14 5.7%	10 4.3%	24 5%
Male	109 44.3%	106 45.7%	215 45%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	10 4.1%	4 1.7%	14 2.9%
Not Hispanic or Latino	112 45.5%	112 48.3%	224 46.9%
Unknown or Not Reported	1 0.4%	0 0%	1 0.2%
Hispanic or Latino	6 2.4%	5 2.2%	11 2.3%
Not Hispanic or Latino	117 47.6%	111 47.8%	228 47.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	6 2.4%	0 0%	6 1.3%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	1 0.4%	1 0.2%
Black or African American	12 4.9%	18 7.8%	30 6.3%
White	90 36.6%	92 39.7%	182 38.1%
More than one race	6 2.4%	0 0%	6 1.3%
Unknown or Not Reported	9 3.7%	5 2.2%	14 2.9%
American Indian or Alaska Native	1 0.4%	0 0%	1 0.2%
Asian	0 0%	1 0.4%	1 0.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	10 4.1%	16 6.9%	26 5.4%
White	103 41.9%	92 39.7%	195 40.8%
More than one race	5 2%	2 0.9%	7 1.5%
Unknown or Not Reported	4 1.6%	5 2.2%	9 1.9%
Region of Enrollment (Count of Participants)
United States	246 100%	232 100%	478 100%
Insulin Use among Patient Participants (Count of Participants)
Count of Participants [Participants]	78 31.7%	64 27.6%	142 29.7%
PAM-13 Cutoff (Count of Participants)
PAM-13 Prorated Score <40	55 22.4%	65 28%	120 25.1%
PAM-13 Prorated Score >40	68 27.6%	51 22%	119 24.9%
Care Partner Lives with Patient Participant (Count of Participants)
Count of Participants [Participants]	86 35%	82 35.3%	168 35.1%
Patient Baseline Patient Activation Measure (PAM-13) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	62.8 (11.2)	59.8 (12.6)	61.3 (12.0)
Baseline UKPDS 5-Year Cardiac Risk Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	14.7 (10.0)	13.6 (9.9)	14.2 (9.9)
Enrolled at Hospital-based clinic (vs. community clinic site) (Count of Participants)
Count of Participants [Participants]	78 31.7%	87 37.5%	165 34.5%

Outcome Measures

1. Primary Outcome

Title	Change in Patient Activation, as Measured by Patient Activation Measure - 13
Description	Patient Activation Measure-13. Range of potential values (0,100), higher scores mean a better outcome, Outcome is the participant's difference in the measure between baseline and 12 months, among patient participants
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description
This outcome was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population.

Arm/Group Title	CO-IMPACT	PACT
Arm/Group Description	patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Measure Participants	123	116
Mean (Standard Deviation) [units on a scale]	2.94 (9.86)	1.78 (10.84)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CO-IMPACT, PACT
	Comments	The null hypothesis was that change (baseline to 12 months) in PAM is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' PAM score compared to patient participants in PACT.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.048
	Comments
	Method	Regression, Linear
	Comments	Model was adjusted for baseline value of PAM, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.60
	Confidence Interval	(2-Sided) 95% 0.02 to 5.18
	Parameter Dispersion	Type: Value:
	Estimation Comments	Net difference defined as 12 months minus baseline

2. Primary Outcome

Title	Change in Cardiac Event 5-year Risk Score, as Measured by UKPDS Risk Engine
Description	UKPDS Risk Engine, among patient participants only, range is 0 to 100% risk of cardiac event over the next 5 years. Lower score equals a better outcome. Outcome is the participant's difference in the measure between baseline and 12 months.
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description
This outcome was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population.

Arm/Group Title	CO-IMPACT	PACT
Arm/Group Description	patient and supporter (dyad) receive one coaching session on action planning, communicating with providers, navigation skills and support skills; preparation by phone before patients? primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter	patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits PACT: participants will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits
Measure Participants	123	116
Mean (Standard Deviation) [units on a scale]	0.14 (6.77)	-0.73 (6.51)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CO-IMPACT, PACT
	Comments	The null hypothesis was that change (baseline to 12 months) in ukpds 5 year risk score is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly decrease patient participants' 5-year cardiovascular event risk.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.32
	Comments
	Method	Regression, Linear
	Comments	Model adjusted for baseline value of ukpds, insulin use, site, randomization stratification variables: care partner not in home and PAM cutoff of 40

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95% -0.87 to 2.67
	Parameter Dispersion	Type: Value:
	Estimation Comments	Net difference defined as 12 months minus baseline. Reference for comparison is PACT.

3. Secondary Outcome

Title	Change in Diabetes Self-Management Behavior - Healthy Eating
Description	Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values for healthy eating subscale (0 - 7 days per week), higher scores mean better outcomes, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description
The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Arm/Group Title	CO-IMPACT	PACT
Arm/Group Description	patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Measure Participants	116	113
Mean (Standard Deviation) [score on a scale]	1.12 (2.30)	0.50 (2.54)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CO-IMPACT, PACT
	Comments	The null hypothesis was that change (baseline to 12 months) in Healthy Eating is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly change patient participants' Healthy Eating scores compared to patient participants in PACT.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	Regression, Linear
	Comments	Model adjusted for BL value of Healthy Eating, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.71
	Confidence Interval	(2-Sided) 95% 0.20 to 1.22
	Parameter Dispersion	Type: Value:
	Estimation Comments	Net difference defined as 12 months minus baseline

4. Secondary Outcome

Title	Change in Glycemic Control
Description	Hemoglobin A1c, among patient participants. Common range is 4% to 14%, lower values indicate better outcomes. Outcome is the participant's difference in the measure between baseline and 12 months.
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description
The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Arm/Group Title	CO-IMPACT	PACT
Arm/Group Description	patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Measure Participants	114	113
Mean (Standard Deviation) [percent of glycosylated hemoglobin]	-0.05 (1.38)	-0.28 (1.43)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CO-IMPACT, PACT
	Comments	The null hypothesis was that change (baseline to 12 months) in A1c is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly decrease patient participants' A1c score compared to patient participants in PACT.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.33
	Comments
	Method	Regression, Linear
	Comments	Model was adjusted for baseline value of A1c, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.17
	Confidence Interval	(2-Sided) 95% -0.17 to 0.51
	Parameter Dispersion	Type: Value:
	Estimation Comments	Net difference defined as 12 months minus baseline

5. Secondary Outcome

Title	Change in Systolic Blood Pressure
Description	mmHg, Average of two readings done at each time point. Common physiologic range is 80mmHg - 220mmHg. Lower values indicate better outcomes, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description
The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Arm/Group Title	CO-IMPACT	PACT
Arm/Group Description	patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Measure Participants	110	110
Mean (Standard Deviation) [mmHg]	-6.41 (1.75)	-2.46 (1.77)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CO-IMPACT, PACT
	Comments	The null hypothesis was that change (baseline to 12 months) in SBP is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly decrease patient participants' SBP score compared to patient participants in PACT.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.18
	Comments
	Method	Regression, Linear
	Comments	Model was adjusted for baseline value of SBP, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40.

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-2.82
	Confidence Interval	(2-Sided) 95% -7.00 to 1.35
	Parameter Dispersion	Type: Value:
	Estimation Comments	Net difference defined as 12 months minus baseline

6. Secondary Outcome

Title	Change in Diabetes Distress
Description	Problem Areas in Diabetes Scale (PAID) - range of potential values (0,20), higher scores indicate worse outcomes (greater diabetes-related emotional distress), among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description
The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Arm/Group Title	CO-IMPACT	PACT
Arm/Group Description	patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Measure Participants	114	111
Mean (Standard Deviation) [score on a scale]	-0.25 (4.06)	-0.62 (4.60)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CO-IMPACT, PACT
	Comments	The null hypothesis was that change (baseline to 12 months) in PAID is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' PAID score compared to patient participants in PACT.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.83
	Comments
	Method	Regression, Linear
	Comments	Model was adjusted for baseline value of PAID, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.12
	Confidence Interval	(2-Sided) 95% -0.95 to 1.19
	Parameter Dispersion	Type: Value:
	Estimation Comments	Net difference defined as 12 months minus baseline

7. Secondary Outcome

Title	Change in Activation in Health Encounters
Description	Perceived Efficacy in Patient-Physician Interactions (PEPPI-5) - range of potential values (5, 25), higher scores indicate better outcomes (higher perceived self-efficacy in patient-physician interactions), among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description
The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Arm/Group Title	CO-IMPACT	PACT
Arm/Group Description	patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Measure Participants	115	113
Mean (Standard Deviation) [score on a scale]	0.23 (3.41)	0.33 (4.01)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CO-IMPACT, PACT
	Comments	The null hypothesis was that change (baseline to 12 months) in PEPPI is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' PEPPI score compared to patient participants in PACT.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.79
	Comments
	Method	Regression, Linear
	Comments	Model was adjusted for baseline value of PEPPI, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.11
	Confidence Interval	(2-Sided) 95% -0.71 to 0.93
	Parameter Dispersion	Type: Value:
	Estimation Comments	Net difference defined as 12 months minus baseline

8. Secondary Outcome

Title	Change in Non-Fasting Lipid Levels
Description	Total cholesterol mg/DL to HDL mg/DL Ratio, common range is 1-10, lower values indicate better outcomes, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description
The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Arm/Group Title	CO-IMPACT	PACT
Arm/Group Description	patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Measure Participants	114	113
Mean (Standard Deviation) [mg/dL]	-0.11 (0.99)	-0.21 (1.01)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CO-IMPACT, PACT
	Comments	The null hypothesis was that change (baseline to 12 months) in Chol to HDL Ratio is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly decrease patient participants' Chol to HDL Ratio score compared to patient participants in PACT.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.21
	Comments
	Method	Regression, Linear
	Comments	Model adjusted for BL value of Cho to HDL Ratio, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40.

Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	0.15
	Confidence Interval	(2-Sided) 95% -0.09 to 0.40
	Parameter Dispersion	Type: Value:
	Estimation Comments	Net difference defined as 12 months minus baseline

9. Secondary Outcome

Title	Change in Patient Satisfaction With Healthcare System Support for Family Supporter
Description	Measured as percent of patient participants answering they were 'very satisfied' or 'satisfied' with healthcare system support for their Care Partner (family supporter)'s participation in their healthcare. Response options were 'very unsatisfied', 'unsatisfied', 'neither', 'satisfied', or 'very satisfied'. Increase in proportion of 'very satisfied' or 'satisfied' indicates better outcomes (higher satisfaction), among patient participants.
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description
The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Arm/Group Title	CO-IMPACT	PACT
Arm/Group Description	patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Measure Participants	115	111
Number moving from not satisfied/neither to satisfied	35 14.2%	20 8.6%
Those not changing or getting worse	80 32.5%	91 39.2%

10. Secondary Outcome

Title	Change in Supporter Use of Autonomy-Supportive Communication
Description	Important Other Climate Questionnaire (IOCQ) - patient rating of supporter communication. Range of potential values (1,7), higher scores indicate better outcomes (higher patient perception of supporter use of autonomy supportive communication), among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description
The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Arm/Group Title	CO-IMPACT	PACT
Arm/Group Description	patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Measure Participants	110	113
Mean (Standard Deviation) [score on a scale]	0.27 (0.93)	0.05 (0.94)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CO-IMPACT
	Comments	The null hypothesis was that change (baseline to 12 months) in IOCQ is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' IOCQ score compared to patient participants in PACT.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	Regression, Linear
	Comments	Model was adjusted for baseline value of IOCQ, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.30
	Confidence Interval	(2-Sided) 95% 0.08 to 0.53
	Parameter Dispersion	Type: Value:
	Estimation Comments	Net difference defined as 12 months minus baseline

11. Secondary Outcome

Title	Change in Smoking Status
Description	Global Adult Tobacco Survey, values include 'current smoker', 'former smoker', or 'never smoker'. Change from current to former smoker over 12 months indicates a better outcome. Measured among patient participants.
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description
The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Arm/Group Title	CO-IMPACT	PACT
Arm/Group Description	patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Measure Participants	115	113
Changed from active smoker at baseline to non-smoker at 12 months	2 0.8%	3 1.3%
Changed from non-smoker at baseline to smoker at 12 months	1 0.4%	5 2.2%
No change	112 45.5%	105 45.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CO-IMPACT, PACT
	Comments
	Type of Statistical Test	Equivalence
	Comments	Equivalent distribution among categories

Statistical Test of Hypothesis	p-Value	0.17
	Comments
	Method	Chi-squared
	Comments

Method of Estimation	Estimation Parameter	difference in count
	Estimated Value	-1
	Confidence Interval	(2-Sided) % to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Other Statistical Analysis		Difference in count of those who stopped smoking in CO-IMPACT vs. those who stopped smoking in PACT.

12. Secondary Outcome

Title	Change in Diabetes Self-Management Behavior - Physical Activity
Description	Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values for physical activity subscale (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description
The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Arm/Group Title	CO-IMPACT	PACT
Arm/Group Description	patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Measure Participants	115	113
Mean (Standard Deviation) [score on a scale]	0.09 (2.46)	0.46 (2.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CO-IMPACT, PACT
	Comments	The null hypothesis was that change (baseline to 12 months) in Physical activity is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Physical activity score compared to patient participants in PACT.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.87
	Comments
	Method	Regression, Linear
	Comments	Model adjusted for BL value of Physical Activity, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.04
	Confidence Interval	(2-Sided) 95% -0.56 to 0.47
	Parameter Dispersion	Type: Value:
	Estimation Comments	Net difference defined as 12 months minus baseline

13. Secondary Outcome

Title	Change in Diabetes Self-Management Behavior - Blood Sugar Home Testing
Description	Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description
The outcome was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Arm/Group Title	CO-IMPACT	PACT
Arm/Group Description	patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Measure Participants	101	94
Mean (Standard Deviation) [score on a scale]	0.17 (1.75)	0.19 (1.80)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CO-IMPACT, PACT
	Comments	The null hypothesis was that change (baseline to 12 months) in Blood Sugar Home Testing is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Blood Sugar Home Testing score compared to patient participants in PACT.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.31
	Comments
	Method	Regression, Linear
	Comments	Model adjusted for BL value of Blood Sugar Home Testing, insulin use, randomization strat. variables: care partner not in home and PAM cutoff of 40

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.23
	Confidence Interval	(2-Sided) 95% -0.22 to 0.68
	Parameter Dispersion	Type: Value:
	Estimation Comments	Net difference defined as 12 months minus baseline

14. Secondary Outcome

Title	Change in Diabetes Self-Management Behavior - Blood Pressure Home Testing
Description	Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description

This outcome was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Arm/Group Title	CO-IMPACT	PACT
Arm/Group Description	patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Measure Participants	75	62
Mean (Standard Deviation) [score on a scale]	0.51 (2.52)	0.48 (1.88)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CO-IMPACT, PACT
	Comments	The null hypothesis was that change (baseline to 12 months) in Blood Pressure Home Testing is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Blood Pressure Home Testing score compared to patient participants in PACT.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.87
	Comments
	Method	Regression, Linear
	Comments	Model adjusted for BL value of Blood Pressure Home Testing, insulin use, randomization strat. variables: care partner not in home and PAM cutoff of 40

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.07
	Confidence Interval	(2-Sided) 95% -0.76 to 0.89
	Parameter Dispersion	Type: Value:
	Estimation Comments	Net difference defined as 12 months minus baseline

15. Secondary Outcome

Title	Change in Diabetes Self-Management Behavior - Take Oral Meds as Prescribed
Description	Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description
The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Arm/Group Title	CO-IMPACT	PACT
Arm/Group Description	patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Measure Participants	99	96
Mean (Standard Deviation) [score on a scale]	0.14 (1.17)	0.23 (1.30)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CO-IMPACT, PACT
	Comments	The null hypothesis was that change (baseline to 12 months) in Take Oral Meds as Prescribed is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Take Oral Meds as Prescribed score compared to patient participants in PACT.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.56
	Comments
	Method	Regression, Linear
	Comments	Model adjusted for BL value of Take Oral Meds as Prescribed, insulin use, randomization strat variables: care partner not in home and PAM cutoff of 40

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.10
	Confidence Interval	(2-Sided) 95% -0.42 to 0.23
	Parameter Dispersion	Type: Value:
	Estimation Comments	Net difference defined as 12 months minus baseline

16. Secondary Outcome

Title	Change in Diabetes Self-Management Behavior - Take Insulin as Prescribed
Description	Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description
The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Arm/Group Title	CO-IMPACT	PACT
Arm/Group Description	patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Measure Participants	73	61
Mean (Standard Deviation) [score on a scale]	0.14 (1.34)	0.48 (2.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CO-IMPACT, PACT
	Comments	The null hypothesis was that change (baseline to 12 months) in Take Insulin as prescribed is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Take Insulin as Prescribed compared to patient participants in PACT.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.67
	Comments
	Method	Regression, Linear
	Comments	Model adjusted for baseline value of Take Insulin as Prescribed, randomization stratification variables: care partner not in home and PAM cutoff of 40

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.07
	Confidence Interval	(2-Sided) 95% -0.26 to 0.41
	Parameter Dispersion	Type: Value:
	Estimation Comments	Net difference defined as 12 months minus baseline

17. Secondary Outcome

Title	Change in Diabetes Self-Management Behavior - Check Feet
Description	Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description
The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Arm/Group Title	CO-IMPACT	PACT
Arm/Group Description	patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Measure Participants	115	113
Mean (Standard Deviation) [score on a scale]	0.72 (2.06)	0.72 (2.26)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CO-IMPACT, PACT
	Comments
	Type of Statistical Test	Superiority
	Comments	The null hypothesis was that change (baseline to 12 months) in Foot Care is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Foot Care score compared to patient participants in PACT.

Statistical Test of Hypothesis	p-Value	0.29
	Comments
	Method	Regression, Linear
	Comments	Model was adjusted for baseline value of Foot Care, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40

Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	0.26
	Confidence Interval	(2-Sided) 95% -0.22 to 0.75
	Parameter Dispersion	Type: Value:
	Estimation Comments

Other Statistical Analysis		Net difference defined as 12 months minus baseline

18. Other Pre-specified Outcome

Title	Change in Diabetes Self-Efficacy
Description	Adapted Stanford Chronic Disease self-efficacy scale, among patient participants. Range of potential values (1,10), higher score indicates higher self-efficacy. Outcome is the participant's difference in the measure between baseline and 12 months.
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description
The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Arm/Group Title	CO-IMPACT	PACT
Arm/Group Description	patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Measure Participants	115	113
Mean (Standard Deviation) [score on a scale]	0.26 (1.38)	0.23 (1.48)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CO-IMPACT, PACT
	Comments	The null hypothesis was that change (baseline to 12 months) in SE is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly change patient participants' SE scores compared to patient participants in PACT.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	Regression, Linear
	Comments	Model was adjusted for baseline value of SE, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.40
	Confidence Interval	(2-Sided) 95% 0.09 to 0.71
	Parameter Dispersion	Type: Value:
	Estimation Comments	Net difference defined as 12 months minus baseline

19. Other Pre-specified Outcome

Title	Change in Supporter Self-Efficacy for Helping With Diabetes Care
Description	Adapted Stanford Chronic Disease self-efficacy scale, among family supporter participants. Range of potential values (1,10), higher score indicates higher self-efficacy. Outcome is the participant's difference in the measure between baseline and 12 months.
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description
The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Arm/Group Title	CO-IMPACT	PACT
Arm/Group Description	patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Measure Participants	108	110
Mean (Standard Deviation) [score on a scale]	0.19 (1.77)	0.29 (1.83)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CO-IMPACT, PACT
	Comments	The null hypothesis was that change (baseline to 12 months) in Lorig_CP is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Lorig_CP score compared to patient participants in PACT.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.67
	Comments
	Method	Regression, Linear
	Comments	Model was adjusted for baseline value of Lorig_CP, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.10
	Confidence Interval	(2-Sided) 95% -0.34 to 0.55
	Parameter Dispersion	Type: Value:
	Estimation Comments	Net difference defined as 12 months minus baseline

20. Other Pre-specified Outcome

Title	Change in Caregiver Burden
Description	Caregiver Strain Index - range of potential values (0,13), higher scores (7 or more) mean worse outcomes, among family supporter participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description
The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Arm/Group Title	CO-IMPACT	PACT
Arm/Group Description	patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Measure Participants	108	108
Mean (Standard Deviation) [score on a scale]	0.18 (3.77)	-0.54 (3.30)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CO-IMPACT, PACT
	Comments	The null hypothesis was that change (baseline to 12 months) in CSIS is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' CSIS score compared to patient participants in PACT.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.53
	Comments
	Method	Regression, Linear
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.28
	Confidence Interval	(2-Sided) 95% -0.60 to 1.16
	Parameter Dispersion	Type: Value:
	Estimation Comments	Net difference defined as 12 months minus baseline

21. Other Pre-specified Outcome

Title	Change in Supporter Distress About Patient Participant's Diabetes
Description	Adapted Problem Areas In Diabetes Scale (PAID) - range of potential values (0,20), higher scores indicate worse outcomes (greater diabetes-related emotional distress), among family supporter participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description
The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Arm/Group Title	CO-IMPACT	PACT
Arm/Group Description	patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Measure Participants	107	108
Mean (Standard Deviation) [score on a scale]	-0.50 (3.57)	-1.08 (3.71)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CO-IMPACT, PACT
	Comments	The null hypothesis was that change (baseline to 12 months) in PAID_CP is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' PAID_CP score compared to patient participants in PACT.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.50
	Comments
	Method	Regression, Linear
	Comments	Model was adjusted for baseline value of PAID_CP, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.32
	Confidence Interval	(2-Sided) 95% -0.61 to 1.25
	Parameter Dispersion	Type: Value:
	Estimation Comments	Net difference defined as 12 months minus baselineNet difference defined as 12 months minus baseline

Adverse Events

	CO-IMPACT		PACT
Time Frame	Adverse event data were collected during the year participants were enrolled in the study. All participants participated between the dates of 01/03/17 to 06/03/19.
Adverse Event Reporting Description	Definitions of adverse event and serious adverse event used by study team were consistent with the clinicaltrials.gov definitions. Adverse events were collected when self-reported by participants or family members when study staff reached out to schedule or conduct intervention components or assessment visits.

Arm/Group Title	CO-IMPACT		PACT
Arm/Group Description	patient and supporter (dyad) receive one coaching session on action planning, communicating with providers, navigation skills and support skills; preparation by phone before patients? primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter		patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits PACT: participants will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/246 (0.8%)		1/232 (0.4%)
Serious Adverse Events
	CO-IMPACT		PACT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	29/246 (11.8%)		2/232 (0.9%)
Cardiac disorders
Cardiac Events	6/246 (2.4%)	6	0/232 (0%)	0
General disorders
General Diagnoses, Hospitalizations	2/246 (0.8%)	2	1/232 (0.4%)	1
Multiple Issues	1/246 (0.4%)	1	0/232 (0%)	0
Infections and infestations
Infection	4/246 (1.6%)	4	0/232 (0%)	0
Injury, poisoning and procedural complications
Injury	4/246 (1.6%)	4	0/232 (0%)	0
Nervous system disorders
Stroke	4/246 (1.6%)	4	0/232 (0%)	0
Social circumstances
Social Circumstances	1/246 (0.4%)	1	0/232 (0%)	0
Surgical and medical procedures
Surgeries	4/246 (1.6%)	4	0/232 (0%)	0
Vascular disorders
Vascular Issues	3/246 (1.2%)	3	1/232 (0.4%)	1
Other (Not Including Serious) Adverse Events
	CO-IMPACT		PACT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/246 (0%)		0/232 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title	Dr. Ann-Marie Rosland
Organization	VA Pittsburgh Healthcare System, Center for Health Equity Research and Promotion
Phone	4123602259
Email	Ann-Marie.rosland@va.gov

Responsible Party:

VA Office of Research and Development

ClinicalTrials.gov Identifier:

NCT02328326

Other Study ID Numbers:

IIR 14-074

First Posted:

Dec 31, 2014

Last Update Posted:

Oct 6, 2021

Last Verified:

Sep 1, 2021

CO-IMPACT: Caring Others Increasing EngageMent in PACT

Study Details

Study Description

Brief Summary

Detailed Description

Background:

Objectives:

Methods:

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Other Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Patient Inclusion Criteria:

Care Partner Inclusion Criteria:

Exclusion Criteria:

Patient Exclusion Criteria:

Care Partner Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

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Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

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Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

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