Improving Medication Adherence in the Alabama Black Belt

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02274844
• Collaborator: Patient-Centered Outcomes Research Institute (Other), University of Alabama at Birmingham (Other)
• Enrollment: 473
• Location: 1
• Arms: 2
• Actual Duration (Months): 34
• Patients Per Site Per Month: 13.9

Study Details

Study Description

Brief Summary

Medication adherence is especially critical in regions like rural Alabama, where residents have among the worst health outcomes in the US. This project was designed in collaboration with our community member partners and builds on a 5-year partnership of community-engaged research on diabetes peer coaching interventions and our experience with peer storytelling. The investigators will test the hypothesis that an intervention designed within the Corbin and Strauss framework can improve adherence and health outcomes compared to usual care.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus; Medication Adherence	Behavioral: Living Well with Diabetes Program	N/A

Detailed Description

Improving medication adherence is one of the greatest challenges in modern medicine. Despite decades of research on the topic, as many as half of patients with chronic diseases are not taking medications as recommended, and costs of nonadherence have been estimated at $290 billion annually. One reason for this persistent finding could be that interventions rarely acknowledge medications within the larger context of the lived experience of illness. Drawing on hundreds of patient interviews, Corbin and Strauss showed that chronic illness is a fundamentally destabilizing influence that forces us to confront the potential limitations of our "new", chronically ill self. Accepting our illness may be a crucial step in embracing medication adherence and other self-management behaviors as ways to restore balance following this disruption. The Corbin and Strauss framework is not often used to develop and test interventions to improve medication adherence, and this is the central objective of this proposal.

Medication adherence is especially critical in regions like rural Alabama, where residents have among the worst health outcomes in the US. Rates of cardiovascular mortality, diabetes and obesity are very high, but resources are scarce and the area's predominately black residents have deep-seated mistrust of the healthcare system (the region includes Tuskegee, site of the infamous syphilis study). This project was designed in collaboration with our community member partners and builds on a 5-year partnership of community-engaged research on diabetes peer coaching interventions and our experience with peer storytelling. The investigators will test the hypothesis that an intervention designed within the Corbin and Strauss framework can improve adherence and health outcomes compared to usual care. Our Aims are:

Aim 1: With our community partners, using qualitative research methods, build on already developed culturally tailored education material to develop the medication adherence intervention. The intervention will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching. Activities include conducting focus groups with patients; creating the DVDs and the coaching intervention protocol; training peer coaches; and pilot testing.

Aim 2: Conduct a randomized controlled trial with 500 individuals with type 2 diabetes and medication nonadherence. The trial will compare the effect of usual care and the intervention on medication adherence and physiologic risk factors including A1c, blood pressure and low density lipoprotein cholesterol (primary outcomes), and quality of life and self-efficacy (secondary outcomes).

This innovative approach would be a major shift in how patients are helped in under resourced areas living with chronic diseases commit to taking medications, improving health and eventually reducing health disparities.

Study Design

• Study Type: Interventional
• Actual Enrollment: 473 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Improving Medication Adherence in the Alabama Black Belt
• Actual Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: Jan 31, 2019
• Actual Study Completion Date: Jan 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Peer Coaching The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching.	Behavioral: Living Well with Diabetes Program; The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching
No Intervention: Usual Care At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.

Outcome Measures

Primary Outcome Measures

1. Change in Self Reported Medication Adherence [Baseline, 6 months]

   Patient-reported adherence to medications as a medication adherence score, from 0-3, where a higher score indicates worse adherence.

2. Change in Percentage of HbA1c [Baseline, 6 months]

   Hemoglobin A1c test to identify the average amount of glucose (sugar) present in a patient's blood.

3. Change in Blood Pressure [Baseline, 6 months]

   2 BP measures were taken 1 minute apart using a LifeSource UA-789 digital blood pressure monitor.

4. Change in Low-Density Lipoprotein (LDL) Cholesterol [Baseline, 6 months]

   Finger stick, spectrophotometer to measure cholesterol level.

Secondary Outcome Measures

1. Change in Quality of Life as Assessed With the Short Form 12- Mental Component [Baseline, 6 months]

   Short Form-12 Mental Component and Physical Component Summary scores range from 0-100; higher scores indicate greater quality of life.

2. Change in Quality of Life as Assessed With the Short Form-12- Physical Component [Baseline, 6 months]

   Short Form-12 Mental Component and Physical Component Summary scores range from 0-100; higher scores indicate greater quality of life.

3. Change in Medication Use Self-efficacy Score as Measured by SEAMS Scale and the Perceived Diabetes Self-Management Scale, Which is Associated With A1c [Baseline, 6 months]

   Medication use self-efficacy scores for range from 13-39; higher scores indicate higher levels of self-efficacy for medication adherence.

4. Change in Diabetes-Specific Quality of Life [Baseline, 6 months]

   Diabetes specific quality of life will be assessed using the validated Diabetes Distress Scale.The DDS is a 17-item instrument that measures diabetes-related emotional distress. Participants rate the degree to which each item is problematic for them on a 6-point Likert scale, from 1 (no problem) to 6 (serious problem). A score of 3 or greater = moderate distress.

5. Number of Physician Office Visits 6 Months [6 months]

6. Number of Hospital Stays at 6 Months [6 months]

7. Number of Emergency Visits at 6 Months [6 months]

8. Change in Diabetes Medication Counts [Baseline, 6 months]

   Change in number of diabetes medications.

Other Outcome Measures

1. Change in Medication Beliefs- Harm (Beliefs That Medications Are Harmful) [Baseline, 6 months]

   Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.

2. Change in Medication Beliefs- Overuse (Concerns About the Way Doctors Use Medications) [Baseline, 6 months]

   Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.

3. Change in Medication Beliefs-Necessity (Beliefs About the Necessity of Medications) [Baseline, 6 months]

   Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.

4. Change in Medication Beliefs- Concerns (Concerns About the Negative Effects of Medications) [Baseline, 6 months]

   Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• adults

• type 2 diabetes

• taking medications for diabetes

• medication non adherent

Exclusion Criteria:

• nursing home residence

• plans to move away in the next year

• advanced illnesses such as hemodialysis, cancer or dementia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univeristy of Alabama at Birmingham	Birmingham	Alabama	United States	35210

Sponsors and Collaborators

• Weill Medical College of Cornell University
• Patient-Centered Outcomes Research Institute
• University of Alabama at Birmingham

Investigators

• Principal Investigator: Monika M Safford, MD, Weill Medical College of Cornell University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 16, 2016

More Information

Publications

None provided.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT02274844
• Other Study ID Numbers: PCORI-R-AD-1306-03565
• First Posted: Oct 24, 2014
• Last Update Posted: Oct 29, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

Participant Flow

Recruitment Details	Recruitment efforts in this area focused on attending health fairs, posting flyers at community locations such as libraries and churches. The main focus of recruitment was in the county's safety net clinic.

Arm/Group Title	Peer Coaching	Usual Care
Arm/Group Description	The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching. Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching	At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
Period Title: Overall Study
STARTED	203	270
COMPLETED	165	238
NOT COMPLETED	38	32

Baseline Characteristics

Arm/Group Title	Peer Coaching	Usual Care	Total
Arm/Group Description	The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching. Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching	At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.	Total of all reporting groups
Overall Participants	203	270	473
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.7 (10.6)	56.7 (12.1)	57.1 (11.5)
Sex: Female, Male (Count of Participants)
Female	159 78.3%	212 78.5%	371 78.4%
Male	44 21.7%	58 21.5%	102 21.6%
Race/Ethnicity, Customized (Count of Participants)
African American	178 87.7%	250 92.6%	428 90.5%
All Others	25 12.3%	20 7.4%	45 9.5%
Marital Status (Count of Participants)
Married or living with partner	75 36.9%	94 34.8%	169 35.7%
Never married, divorced, widowed, separated	128 63.1%	175 64.8%	303 64.1%
Annual Income (Count of Participants)
<$20,000	133 65.5%	185 68.5%	318 67.2%
>=$20,000	60 29.6%	74 27.4%	134 28.3%
Education (Count of Participants)
< High School	46 22.7%	51 18.9%	97 20.5%
12th grade, GED, HS diploma	69 34%	99 36.7%	168 35.5%
>High School	87 42.9%	120 44.4%	207 43.8%
Employment (Count of Participants)
Employed for wages or self-employed	53 26.1%	72 26.7%	125 26.4%
Not worked(ret, out of wrk, homemker, unable work)	149 73.4%	196 72.6%	345 72.9%
HbA1c (%) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [%]	8.6 (2.2)	8.3 (2.0)	8.4 (2.1)
Hba1c (Count of Participants)
Less than 7.0	73 36%	114 42.2%	187 39.5%
7.0 or greater	130 64%	156 57.8%	286 60.5%
Systolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	127.8 (19.4)	129.1 (19.9)	128.6 (19.7)
Body Mass Index (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	36.4 (8.8)	36.5 (8.0)	36.5 (8.4)
Medication Adherence Score as measured by the Morisky Medication Adherence Scale (Count of Participants)
Yes to 0 questions	67 33%	104 38.5%	171 36.2%
Yes to 1 questions	84 41.4%	98 36.3%	182 38.5%
Yes to 2 questions	34 16.7%	40 14.8%	74 15.6%
Yes to 3 questions	12 5.9%	20 7.4%	32 6.8%
Yes to 4 questions	6 3%	7 2.6%	13 2.7%
Missing	0 0%	1 0.4%	1 0.2%
Number of Subjects Taking Insulin (Count of Participants)
Count of Participants [Participants]	96 47.3%	111 41.1%	207 43.8%

Outcome Measures

1. Primary Outcome

Title	Change in Self Reported Medication Adherence
Description	Patient-reported adherence to medications as a medication adherence score, from 0-3, where a higher score indicates worse adherence.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time.

Arm/Group Title	Peer Coaching	Usual Care
Arm/Group Description	The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching. Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching	At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
Measure Participants	164	239
Baseline	0.78 (0.80)	0.74 (0.79)
6 months	0.53 (0.66)	0.62 (0.76)
Change at 6 months	-0.25 (0.70)	-0.12 (0.71)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer Coaching, Usual Care
	Comments	The study was powered to detect clinically meaningful differences in physiologic risk factors; it had four primary outcomes.Power estimates accounted for clustering of patients within towns, using a variance inflation factor, conservatively estimating power for ICC=0.01-0.05. Process measures were selected to understand which aspects of the intervention were particularly effective, assessing both program satisfaction and peer coach effectiveness.
	Type of Statistical Test	Superiority
	Comments	The outcomes were all continuous or ordinal measures, thus unadjusted hypothesis tests used t-tests or the Wilcoxon-Mann-Whitney test, as appropriate, and statistical modeling used linear regression. ANCOVA was used to adjust for baseline covariates with imbalance across treatment arms (race) and baseline values of the measures.
Statistical Test of Hypothesis	p-Value	0.22
	Comments	The main hypotheses tested were that intervention participants would have higher medication adherence and significantly greater improvement in A1c, BP, LDL-C, and measures of quality of life, and self-efficacy compared to control participants.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.09
	Confidence Interval	(2-Sided) 95%; -0.23 to 0.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Change in Percentage of HbA1c
Description	Hemoglobin A1c test to identify the average amount of glucose (sugar) present in a patient's blood.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time.

Arm/Group Title	Peer Coaching	Usual Care
Arm/Group Description	The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching. Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching	At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
Measure Participants	164	239
Baseline	8.4 (2.11)	8.3 (1.99)
6 months	8.1 (1.9)	8.1 (1.8)
Change at 6 months	-0.37 (1.71)	-0.24 (1.55)

3. Primary Outcome

Title	Change in Blood Pressure
Description	2 BP measures were taken 1 minute apart using a LifeSource UA-789 digital blood pressure monitor.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time.

Arm/Group Title	Peer Coaching	Usual Care
Arm/Group Description	The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching. Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching	At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
Measure Participants	164	239
Baseline	128.5 (19.6)	129.3 (19.5)
6 months	130.6 (20.7)	133.6 (18.4)
Change at 6 months	2.5 (19.5)	4.1 (20.5)

4. Primary Outcome

Title	Change in Low-Density Lipoprotein (LDL) Cholesterol
Description	Finger stick, spectrophotometer to measure cholesterol level.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time.

Arm/Group Title	Peer Coaching	Usual Care
Arm/Group Description	The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching. Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching	At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
Measure Participants	164	239
Baseline	84.6 (38.4)	80.7 (36.3)
6 months	80.1 (33.1)	82.2 (31.0)
Change at 6 months	-4.5 (38.6)	1.5 (38.2)

5. Secondary Outcome

Title	Change in Quality of Life as Assessed With the Short Form 12- Mental Component
Description	Short Form-12 Mental Component and Physical Component Summary scores range from 0-100; higher scores indicate greater quality of life.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time.

Arm/Group Title	Peer Coaching	Usual Care
Arm/Group Description	The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching. Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching	At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
Measure Participants	164	239
Baseline	42.7 (7.5)	42.3 (7.0)
6 months	42.0 (6.9)	42.1 (7.2)
Change at 6 months	-0.7 (8.6)	-0.2 (8.5)

6. Secondary Outcome

Title	Change in Quality of Life as Assessed With the Short Form-12- Physical Component
Description	Short Form-12 Mental Component and Physical Component Summary scores range from 0-100; higher scores indicate greater quality of life.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time.

Arm/Group Title	Peer Coaching	Usual Care
Arm/Group Description	The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching. Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching	At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
Measure Participants	164	239
Baseline	39.0 (8.2)	40.1 (7.7)
6 months	40.4 (8.3)	40.4 (7.9)
Change at 6 months	1.4 (7.7)	0.3 (8.1)

7. Secondary Outcome

Title	Change in Medication Use Self-efficacy Score as Measured by SEAMS Scale and the Perceived Diabetes Self-Management Scale, Which is Associated With A1c
Description	Medication use self-efficacy scores for range from 13-39; higher scores indicate higher levels of self-efficacy for medication adherence.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time.

Arm/Group Title	Peer Coaching	Usual Care
Arm/Group Description	The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching. Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching	At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
Measure Participants	164	239
Baseline	31.9 (5.6)	32.2 (6.0)
6 months	33.9 (5.1)	33.1 (5.5)
Change at 6 months	2.0 (5.6)	0.9 (5.0)

8. Secondary Outcome

Title	Change in Diabetes-Specific Quality of Life
Description	Diabetes specific quality of life will be assessed using the validated Diabetes Distress Scale.The DDS is a 17-item instrument that measures diabetes-related emotional distress. Participants rate the degree to which each item is problematic for them on a 6-point Likert scale, from 1 (no problem) to 6 (serious problem). A score of 3 or greater = moderate distress.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

39 participants in the peer coaching arm and 34 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time.

Arm/Group Title	Peer Coaching	Usual Care
Arm/Group Description	The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching. Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching	At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
Measure Participants	164	236
Baseline	2.6 (1.3)	2.3 (1.3)
6 months	1.9 (1.1)	2.0 (1.2)
Change at 6 months	-0.6 (1.3)	-0.3 (1.3)

9. Secondary Outcome

Title	Number of Physician Office Visits 6 Months
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

This data was not collected.

Arm/Group Title	Peer Coaching	Usual Care
Arm/Group Description	The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching. Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching	At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
Measure Participants	0	0

10. Secondary Outcome

Title	Number of Hospital Stays at 6 Months
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

This data was not collected.

Arm/Group Title	Peer Coaching	Usual Care
Arm/Group Description	The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching. Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching	At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
Measure Participants	0	0

11. Secondary Outcome

Title	Number of Emergency Visits at 6 Months
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

This data was not collected.

Arm/Group Title	Peer Coaching	Usual Care
Arm/Group Description	The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching. Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching	At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
Measure Participants	0	0

12. Secondary Outcome

Title	Change in Diabetes Medication Counts
Description	Change in number of diabetes medications.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

44 participants in the peer coaching arm and 38 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time.

Arm/Group Title	Peer Coaching	Usual Care
Arm/Group Description	The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching. Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching	At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
Measure Participants	159	232
Baseline	1.4 (0.7)	1.3 (0.6)
6 months	1.3 (0.6)	1.3 (0.6)
Change at 6 months	-0.04 (0.5)	0.004 (0.6)

13. Other Pre-specified Outcome

Title	Change in Medication Beliefs- Harm (Beliefs That Medications Are Harmful)
Description	Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time.

Arm/Group Title	Peer Coaching	Usual Care
Arm/Group Description	The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching. Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching	At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
Measure Participants	164	239
Baseline	10.6 (2.7)	9.8 (2.8)
Follow-up	9.8 (2.7)	9.7 (2.8)
Change	-0.8 (2.5)	-0.1 (2.8)

14. Other Pre-specified Outcome

Title	Change in Medication Beliefs- Overuse (Concerns About the Way Doctors Use Medications)
Description	Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time.

Arm/Group Title	Peer Coaching	Usual Care
Arm/Group Description	The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching. Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching	At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
Measure Participants	164	239
Baseline	13.3 (3.2)	12.7 (3.4)
Follow-up	12.6 (3.4)	12.6 (3.4)
Change	-0.6 (3.3)	-0.1 (3.3)

15. Other Pre-specified Outcome

Title	Change in Medication Beliefs-Necessity (Beliefs About the Necessity of Medications)
Description	Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time.

Arm/Group Title	Peer Coaching	Usual Care
Arm/Group Description	The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching. Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching	At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
Measure Participants	164	239
Baseline	19.1 (3.6)	19.6 (3.9)
Follow-up	20.0 (3.9)	19.4 (4.2)
Change	0.9 (3.5)	-0.2 (3.7)

16. Other Pre-specified Outcome

Title	Change in Medication Beliefs- Concerns (Concerns About the Negative Effects of Medications)
Description	Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time.

Arm/Group Title	Peer Coaching	Usual Care
Arm/Group Description	The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching. Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching	At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
Measure Participants	164	239
Baseline	15.4 (3.9)	14.9 (4.2)
Follow-up	14.0 (3.8)	14.7 (8.9)
Change	-1.5 (4.0)	-0.2 (3.9)

Adverse Events

Time Frame	6 months
Arm/Group Title	Peer Coaching		Usual Care
Arm/Group Description	The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching. Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching		At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
All Cause Mortality
	Peer Coaching		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/203 (0%)		0/270 (0%)
Serious Adverse Events
	Peer Coaching		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/203 (0%)		0/270 (0%)
Other (Not Including Serious) Adverse Events
	Peer Coaching		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/203 (0%)		0/270 (0%)

Limitations/Caveats

Delays in follow-up data collection for some participants could impact the A1c findings, medication adherence was not measured using objective means, and participants in this sample were mostly women, possibly limiting generalizability to men.

More Information

Certain Agreements

Principal Investigators are NOT 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.