INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) Study

• Sponsor: Emory University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02022111
• Collaborator: National Institute of Mental Health (NIMH) (NIH), University of Washington (Other), Madras Diabetes Research Foundation (Other), All India Institute of Medical Sciences, New Delhi (Other), Endocrine & Diabetes Centre (Other), Diacon Hospital (Other)
• Enrollment: 404
• Locations: 4
• Arms: 2
• Duration (Months): 66.9
• Patients Per Site: 101
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

To provide better care and preventive services for people with both depression and diabetes, the investigators propose to develop and test whether interventions to reduce depressive symptoms can be integrated into routine diabetes clinics in India. The investigators will gather feedback from patients in India through focus group discussions and individual interviews so they can culturally-adapt a model of combined depression and diabetes care. The investigators will then evaluate the effectiveness and costs of this care model in a trial at four diabetes clinics in India. It is expected that results from this study can guide how to incorporate mental health care into routine diabetes clinics in low-resource settings.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Depression; Cardiovascular Risk Factor	Behavioral: Patient Education and Behavioral Activation; Behavioral: Supporting Self-Care (care coordinators); Other: Psychiatrist and Diabetologist Reviews; Other: Decision-support Electronic Health Record System; Other: Standard of Care	N/A

Detailed Description

It has been shown that targeting both depression and diabetes control has important synergistic benefits. Since diabetes patients in India tend to access specialists (government or private) for their diabetes and other health care needs, they at least have a point of contact with the health system which can be leveraged to also reduce depressive symptoms. The investigators aim to assess if interventions for depression can be integrated into routine diabetes care delivery with only modest modifications. The integrated multi-condition (depression and diabetes) intervention model merges experiences from TEAMCare and an ongoing trial of cardiovascular disease (CVD) risk reduction in India (CARRS Trial) and involves: 1. enhancing the role of care coordinators and training them in disease management; 2. integrating 'intelligent' technology; and 3. weekly physician oversight to review poorly-controlled cases and make responsive treatment adjustments. The investigators propose to take this model from research to practice using an implementation sciences approach. The investigators will first gather formative qualitative data and endeavor to make the intervention more patient-centered, develop locally-understandable educational materials, and identify ways to overcome stigma of mental health disorders and facilitate trustful therapeutic relationships between care coordinators and patients and their families. The investigators will then evaluate the effectiveness and cost-effectiveness of the intervention model in a randomized controlled trial.

Study Design

• Study Type: Interventional
• Actual Enrollment: 404 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) Study
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Jul 14, 2018
• Actual Study Completion Date: Sep 27, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention Program of Care Patient Education and Behavioral Activation by a Care Coordinator; Supporting Self-Care; Psychiatrist and Diabetologist Reviews; and Decision-support Electronic Health Record System	Behavioral: Patient Education and Behavioral Activation; To stimulate and motivate sustained, effective self-care, patient education materials and behavioral activation techniques that are adapted for the Indian population will be used by care coordinators. Behavioral activation strategies are brief, structured psychological interventions that are based on extensive theoretical and clinical literature, can be delivered by non-specialist providers, can be combined with antidepressant medications, and emphasize reinforcing behaviors to produce improvements in thoughts, mood, and quality of life.; Behavioral: Supporting Self-Care (care coordinators); Care coordinators will: (a) meet with intervention arm patients and collaboratively set treatment goals; (b) provide verbal education regarding diabetes and depression self-care ;(c) will use motivational interviewing and self-efficacy enhancement strategies to promote monitoring of depressive symptoms, glucose, BP; (d) will proactively follow-up to externally monitor depression symptoms and CVD indicators; (e) will enter updated patient indicators into decision-support electronic health record and utilize software outputs to prioritize patients for review; (g) will convene case review meetings with supervising physicians; and (h) will communicate physician-recommended treatment changes to patients and their routine providers.; Other: Psychiatrist and Diabetologist Reviews; Senior psychiatrist and endocrinologist/diabetologist will be involved in weekly offline case review meetings with care coordinators. Case review meetings will be structured: the decision-support electronic health record will help prioritize cases that are new (within 3 weeks of randomization); have moderate/severe depression symptoms (based on Patient Health Questionnaire (PHQ)-9) ≥6 weeks after most recent treatment changes, or continued poor HbA1c, home glucose, BP, or LDL-c control in past 4 weeks; or have not been reviewed for 3 months. Based on patient indicators and current therapies, physicians will recommend treatment changes (initiation, increases, or simplification of medication regimens) which will be communicated by care coordinators to patients and their usual care providers.; Other: Decision-support Electronic Health Record System; The decision-support electronic health record will store patient indicators entered by the Nurse Case Managers (NCM) and provide diabetes and depression care prompts based on an evidence-based treatment algorithm developed from recommended guidelines for control of diabetes and depression, Indian formularies, and TeamCare investigators. The decision-supported electronic health record (DS-EHR) will prioritize patients (new; poorly-controlled; or well-controlled but not reviewed ≥3 months) for case review meetings and promote accountability (physicians must justify rejecting electronic care prompts).
Placebo Comparator: Control Arm Participants randomized to the control arm will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The physicians treating the control arm will also be provided with trainings regarding identification and care for people with depression. The control participants will have no contact with care coordinators and will only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor.	Other: Standard of Care; Participants randomized to the control arm will receive the existing standard care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The physicians treating the control arm will also be provided with trainings regarding identification and care for people with depression. The control participants will have no contact with care coordinators and will only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor.

Outcome Measures

Primary Outcome Measures

1. Percentage of Combined Improvement of Depressive Symptoms and CVD Risk Factors [24-months post-intervention]

   The sustained (24-month) percentage (%) of participants achieving the outcome in each arm for combined depression and CVD risk factor improvements (≥50% reduction in SCL-20 score AND ≥1 of: ≥0.5% reduction in HbA1c, ≥ 5 mmHg reduction in systolic blood pressure (SBP), or ≥10mg/dl reduction LDL-c).

Secondary Outcome Measures

1. Measures of "Common Effect" [12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)]

   The measure of common effect is a modeled composite estimate of patients achieving simultaneous improvements at 12, 24, and 36 months in the continuous measures for the 4 main outcomes of the trial: depression (20-item Symptoms Checklist [SCL-20] score), glycemia (percentage points in hemoglobin A1c), blood pressure (mmHg of BP), and lipids (mg/dl of LDL-cholesterol).The components of the common effect were standardized differences in each continuous outcome. At each time point, the z-score of each outcome was computed. Next, a model was run to examine the average difference between treatment (intervention) and control in the average level of the standardized outcomes. The estimates are z-score differences in the composite continuous measures of the SCL-20, hemoglobin A1c, systolic BP, and LDL-cholesterol and so, if the intervention group was significantly different (or lower) than the values for the usual care group (control arm), then, the estimates would be negative.

2. Proportion of Participants Achieving All 3 CVD Risk Factor Targets in the Two Groups [12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)]

   Proportion of participants in the intervention and usual care groups that achieved all 3 cardiovascular disease risk factor targets: HbA1c≤7.0% and SBP≤130mmHg and LDL≤100 mg/dl.

3. Mean Changes in Each of the Four Main Targets: SCL-20 Score [12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)]

   This outcome was an estimate of mean change, from baseline, of the 20-item Symptoms Checklist Depression Scale (SCL-20; range 0-4; higher scores indicate worse symptoms) for the intervention and usual care groups. The outcome was reported as a change in score from baseline at 12 months, 24 months, and 36 months with 95% confidence intervals.

4. Mean Changes in Each of the Four Main Targets: HbA1c [12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)]

   This outcome looked at mean change in one of the four main target outcome indicators: HbA1c in percentage points between the treatment and usual care groups at 12 months, 24 and 36 months post-intervention.

5. Mean Changes in Each of the Four Main Targets: SBP [12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)]

   This outcome looked at mean change in one of the four main target outcome indicators: Systolic blood pressure (SBP) in mmHg between the treatment and usual care groups at 12 months, 24 and 36 months post-intervention.

6. Mean Changes in Each of the Four Main Targets: LDL-c in mg/dl [12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)]

   This outcome looked at mean change in one of the four main target outcome indicators: LDL-c in mg/dl between the treatment and usual care groups at 12 months, 24 and 36 months post-intervention.

7. Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: SCL-20 [12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)]

   Proportion of participants achieving treatment target or significant reductions in depression control: ≥50% reduction in SCL-20 at 12, 24 and 36 months post-intervention. Greater proportion of participants achieving this target, correlates with better outcome.

8. Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Glycemic Control [12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)]

   Proportion of participants achieving a treatment target of HbA1c ≤ 7.0% or ≥ 0.5% reduction at 12, 24 and 36 months post-intervention. Greater proportion of participants achieving this target, correlates with better outcome.

9. Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Blood Pressure [12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)]

   Proportion of participants achieving treatment targets or significant reductions of blood pressure (BP) control: Systolic blood pressure (SBP) ≤ 130 mmHg or ≥5 mmHg reduction at 12, 24 and 36 months post-intervention. Greater proportion of participants achieving this target, correlates with better outcome.

10. Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Lipid Control [12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)]

    Proportion of participants achieving treatment targets or significant reductions of lipid control: LDL ≤ 100 mg/dl or ≥ 10mg/dl reduction at 12, 24 and 36 months post-intervention. Greater proportion of participants achieving this target, correlates with better outcome.

11. Mean Treatment Satisfaction Scores [12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)]

    Mean charges in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) in the intervention and usual care groups. Score range is 0-6. Higher score is associated with better outcome.

12. Mean Health Expenditures (Direct Medical Costs) [12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)]

    Mean of direct medical costs for consultations, diagnostic tests, medications, hospital admissions, and/or surgeries or procedures) among participants in the treatment and usual care groups.

13. Cost Utility in the Treatment Arm and Usual Care Arms [12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)]

    The ratio of total costs, which include health expenditures by participants plus clinic or study costs to deliver the intervention and the relative gain or loss in health utilities (measured by the health utilities index). The within-trial cost-utility of intervention was compared to usual care, an incremental cost-utility ratio will be calculated [net costs to net utility: costs(intervention) - costs(control) / utility(intervention) - utility(control)]. The chosen measure of utility is the closest option to a global measure, the quality adjusted life year [QALY] and is calculated as the sum of mean survival time [life years] x utility scores at 6, 12, 18, 24 and 36 months.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age ≥35 years

• Confirmed diagnosis of diabetes (documented glucose tolerance test or 2 venous glucose levels)

• PHQ-9 score≥10

• ≥1 poorly-controlled CVD risk factor (either HbA1c≥8.0% or SBP≥140 mmHg or LDL≥130 mg/dl), irrespective of medications used

• Willingness to consent to randomization.

Exclusion Criteria:

• The patient reports a "3" on the PHQ-9 questionnaire suicide item (Item No:9) which reflects very high suicide risk or the patient's PHQ-9 score is above 23 indicating severe depression requiring immediate referral

• Any participant reporting a "2" on the PHQ-9 suicide item (Item No:9) will be reviewed carefully and if considered too high risk, the participant will be excluded from enrollment in the trial and referred for more intensive psychiatric care.

• Already in psychiatrist's care or using antipsychotic or mood stabilizer medication or diagnosed dementia or bipolar disorder or schizophrenia (based on bipolar and schizophrenia modules of the MINI)

• Diabetes secondary to uncommon causes (e.g., chronic pancreatitis)

• Pregnancy or breastfeeding

• Documented CVD event (MI, stroke) in past 12 months

• End-stage renal disease awaiting transplant

• Malignancy or life-threatening disease with death probable in 3 years

• Alcohol or drug abuse

• No fixed address or contact details.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Diacon Hospital, Diabetes Care and Research Center	Bangalore		India
2	Madras Diabetes Research Foundation	Chennai		India
3	All India Institute of Medical Sciences	Delhi		India
4	Endocrine Diabetes Center	Visakhapatnam		India

Sponsors and Collaborators

• Emory University
• National Institute of Mental Health (NIMH)
• University of Washington
• Madras Diabetes Research Foundation
• All India Institute of Medical Sciences, New Delhi
• Endocrine & Diabetes Centre
• Diacon Hospital

Investigators

• Principal Investigator: Viswanathan Mohan, MD, PhD, Dr Mohan's Diabetes Specialities Clinic
• Principal Investigator: Mohammed K Ali, MBChB, MSc, Emory University
• Principal Investigator: Lydia Chwastiak, MD, University of Washington

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 28, 2018
• Informed Consent Form - May 29, 2017

More Information

Publications

• CARRS Trial Writing Group, Shah S, Singh K, Ali MK, Mohan V, Kadir MM, Unnikrishnan AG, Sahay RK, Varthakavi P, Dharmalingam M, Viswanathan V, Masood Q, Bantwal G, Khadgawat R, Desai A, Sethi BK, Shivashankar R, Ajay VS, Reddy KS, Narayan KM, Prabhakaran D, Tandon N. Improving diabetes care: multi-component cardiovascular disease risk reduction strategies for people with diabetes in South Asia--the CARRS multi-center translation trial. Diabetes Res Clin Pract. 2012 Nov;98(2):285-94. doi: 10.1016/j.diabres.2012.09.023. Epub 2012 Oct 22.
• Detsky AS, Naglie IG. A clinician's guide to cost-effectiveness analysis. Ann Intern Med. 1990 Jul 15;113(2):147-54. Review.
• Donabedian A. The end results of health care: Ernest Codman's contribution to quality assessment and beyond. Milbank Q. 1989;67(2):233-56; discussion 257-67.
• Katon WJ, Lin EH, Von Korff M, Ciechanowski P, Ludman EJ, Young B, Peterson D, Rutter CM, McGregor M, McCulloch D. Collaborative care for patients with depression and chronic illnesses. N Engl J Med. 2010 Dec 30;363(27):2611-20. doi: 10.1056/NEJMoa1003955.

• Responsible Party: Mohammed K Ali, MD, MSc, MBA, Associate Professor, Emory University
• ClinicalTrials.gov Identifier: NCT02022111
• Other Study ID Numbers: IRB00064913; R01MH100390-01
• First Posted: Dec 27, 2013
• Last Update Posted: May 3, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Diabetes Mellitus; Depression; Depressive Disorder

Study Results

Participant Flow

Recruitment Details	Once informed consent was obtained, a blinded outcomes assessor conducted a detailed baseline assessment. Following this, blinded study staff assigned participants to receive intervention or usual care using a password-protected web-based data management system (Interactive Web Response System [IWRS]).

Arm/Group Title	Intervention Program of Care	Control Arm
Arm/Group Description	Includes 4 components: Patient Education and Behavioral Activation by a Care Coordinator; Supporting Self-Care; Psychiatrist and Diabetologist Reviews; and Decision-support Electronic Health Record System	Will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The control participants only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor.
Period Title: Overall Study
STARTED	196	208
COMPLETED	186	193
NOT COMPLETED	10	15

Baseline Characteristics

Arm/Group Title	Intervention Program of Care	Control Arm	Total
Arm/Group Description	Includes 4 components: Patient Education and Behavioral Activation by a Care Coordinator; Supporting Self-Care; Psychiatrist and Diabetologist Reviews; and Decision-support Electronic Health Record System	Will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The control participants only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor.	Total of all reporting groups
Overall Participants	196	208	404
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.1 (8.2)	53.3 (8.9)	53.0 (8.6)
Sex: Female, Male (Count of Participants)
Female	107 54.6%	132 63.5%	239 59.2%
Male	89 45.4%	76 36.5%	165 40.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	196 100%	208 100%	404 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
India	196 100%	208 100%	404 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Combined Improvement of Depressive Symptoms and CVD Risk Factors
Description	The sustained (24-month) percentage (%) of participants achieving the outcome in each arm for combined depression and CVD risk factor improvements (≥50% reduction in SCL-20 score AND ≥1 of: ≥0.5% reduction in HbA1c, ≥ 5 mmHg reduction in systolic blood pressure (SBP), or ≥10mg/dl reduction LDL-c).
Time Frame	24-months post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Program of Care	Control Arm
Arm/Group Description	Includes 4 components: Patient Education and Behavioral Activation by a Care Coordinator; Supporting Self-Care; Psychiatrist and Diabetologist Reviews; and Decision-support Electronic Health Record System	Will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The control participants only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor.
Measure Participants	196	208
Number [percentage of participants]	71.6 36.5%	54.7 26.3%

2. Secondary Outcome

Title	Measures of "Common Effect"
Description	The measure of common effect is a modeled composite estimate of patients achieving simultaneous improvements at 12, 24, and 36 months in the continuous measures for the 4 main outcomes of the trial: depression (20-item Symptoms Checklist [SCL-20] score), glycemia (percentage points in hemoglobin A1c), blood pressure (mmHg of BP), and lipids (mg/dl of LDL-cholesterol).The components of the common effect were standardized differences in each continuous outcome. At each time point, the z-score of each outcome was computed. Next, a model was run to examine the average difference between treatment (intervention) and control in the average level of the standardized outcomes. The estimates are z-score differences in the composite continuous measures of the SCL-20, hemoglobin A1c, systolic BP, and LDL-cholesterol and so, if the intervention group was significantly different (or lower) than the values for the usual care group (control arm), then, the estimates would be negative.
Time Frame	12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Difference Between Intervention Program of Care Arm and Control Arm
Arm/Group Description	The Intervention group includes 4 components: Patient Education and Behavioral Activation by a Care Coordinator; supporting Self-Care; psychiatrist and diabetologist reviews; and decision-support Electronic Health Record System The control Group received standard of care and were contacted only at 6 months intervals for assessment by the blinded outcomes assessor.
Measure Participants	404
12 months post-intervention	-0.2250
24 months post-intervention	-0.1118
36 months post-intervention	0.0434

3. Secondary Outcome

Title	Proportion of Participants Achieving All 3 CVD Risk Factor Targets in the Two Groups
Description	Proportion of participants in the intervention and usual care groups that achieved all 3 cardiovascular disease risk factor targets: HbA1c≤7.0% and SBP≤130mmHg and LDL≤100 mg/dl.
Time Frame	12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Program of Care	Control Arm
Arm/Group Description	Includes 4 components: Patient Education and Behavioral Activation by a Care Coordinator; Supporting Self-Care; Psychiatrist and Diabetologist Reviews; and Decision-support Electronic Health Record System	Will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The control participants only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor.
Measure Participants	196	208
12 months post-intervention	15.3 7.8%	5.5 2.6%
24 months post-intervention	7.10 3.6%	7.30 3.5%
36 months post-intervention	3.10 1.6%	2.40 1.2%

4. Secondary Outcome

Title	Mean Changes in Each of the Four Main Targets: SCL-20 Score
Description	This outcome was an estimate of mean change, from baseline, of the 20-item Symptoms Checklist Depression Scale (SCL-20; range 0-4; higher scores indicate worse symptoms) for the intervention and usual care groups. The outcome was reported as a change in score from baseline at 12 months, 24 months, and 36 months with 95% confidence intervals.
Time Frame	12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Program of Care	Control Arm
Arm/Group Description	Includes 4 components: Patient Education and Behavioral Activation by a Care Coordinator; Supporting Self-Care; Psychiatrist and Diabetologist Reviews; and Decision-support Electronic Health Record System	Will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The control participants only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor.
Measure Participants	196	208
12 months Post-intervention SCL-20	-0.79	-0.55
24 months Post-intervention SCL-20	-0.94	-0.86
36 months Post-intervention SCL-20	-0.93	-0.96

5. Secondary Outcome

Title	Mean Changes in Each of the Four Main Targets: HbA1c
Description	This outcome looked at mean change in one of the four main target outcome indicators: HbA1c in percentage points between the treatment and usual care groups at 12 months, 24 and 36 months post-intervention.
Time Frame	12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Program of Care	Control Arm
Arm/Group Description	Includes 4 components: Patient Education and Behavioral Activation by a Care Coordinator; Supporting Self-Care; Psychiatrist and Diabetologist Reviews; and Decision-support Electronic Health Record System	Will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The control participants only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor.
Measure Participants	196	208
12 months Post-intervention HbA1c	-1.12	-0.54
24 months Post-intervention HbA1c	-0.49	-0.24
36 months Post-intervention HbA1c	0.12	-0.02

6. Secondary Outcome

Title	Mean Changes in Each of the Four Main Targets: SBP
Description	This outcome looked at mean change in one of the four main target outcome indicators: Systolic blood pressure (SBP) in mmHg between the treatment and usual care groups at 12 months, 24 and 36 months post-intervention.
Time Frame	12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Program of Care	Control Arm
Arm/Group Description	Includes 4 components: Patient Education and Behavioral Activation by a Care Coordinator; Supporting Self-Care; Psychiatrist and Diabetologist Reviews; and Decision-support Electronic Health Record System	Will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The control participants only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor.
Measure Participants	196	208
12 months Post-intervention SBP	-6.95	-5.91
24 months Post-intervention SBP	-9.81	-9.12
36 months Post-intervention SBP	-2.43	-3.69

7. Secondary Outcome

Title	Mean Changes in Each of the Four Main Targets: LDL-c in mg/dl
Description	This outcome looked at mean change in one of the four main target outcome indicators: LDL-c in mg/dl between the treatment and usual care groups at 12 months, 24 and 36 months post-intervention.
Time Frame	12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Program of Care	Control Arm
Arm/Group Description	Includes 4 components: Patient Education and Behavioral Activation by a Care Coordinator; Supporting Self-Care; Psychiatrist and Diabetologist Reviews; and Decision-support Electronic Health Record System	Will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The control participants only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor.
Measure Participants	196	208
12 months Post-intervention LDL-c	-9.47	-7.04
24 months Post-intervention LDL-c	-5.10	-5.16
36 months Post-intervention LDL-c	9.33	7.65

8. Secondary Outcome

Title	Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: SCL-20
Description	Proportion of participants achieving treatment target or significant reductions in depression control: ≥50% reduction in SCL-20 at 12, 24 and 36 months post-intervention. Greater proportion of participants achieving this target, correlates with better outcome.
Time Frame	12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Program of Care	Control Arm
Arm/Group Description	Includes 4 components: Patient Education and Behavioral Activation by a Care Coordinator; Supporting Self-Care; Psychiatrist and Diabetologist Reviews; and Decision-support Electronic Health Record System	Will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The control participants only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor.
Measure Participants	196	208
SCL-20 12 months -Post-intervention	75.0	48.0
SCL-20 24 months -Post-intervention	82.9	68.8
SCL-20 36 months -Post-intervention	75.2	73.3

9. Secondary Outcome

Title	Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Glycemic Control
Description	Proportion of participants achieving a treatment target of HbA1c ≤ 7.0% or ≥ 0.5% reduction at 12, 24 and 36 months post-intervention. Greater proportion of participants achieving this target, correlates with better outcome.
Time Frame	12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Program of Care	Control Arm
Arm/Group Description	Includes 4 components: Patient Education and Behavioral Activation by a Care Coordinator; Supporting Self-Care; Psychiatrist and Diabetologist Reviews; and Decision-support Electronic Health Record System	Will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The control participants only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor.
Measure Participants	196	208
HbA1c 12 months -Post-intervention	69.6	52.5
HbA1c 24 months -Post-intervention	53.9	49.0
HbA1c 36 months -Post-intervention	50.0	46.4

10. Secondary Outcome

Title	Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Blood Pressure
Description	Proportion of participants achieving treatment targets or significant reductions of blood pressure (BP) control: Systolic blood pressure (SBP) ≤ 130 mmHg or ≥5 mmHg reduction at 12, 24 and 36 months post-intervention. Greater proportion of participants achieving this target, correlates with better outcome.
Time Frame	12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Program of Care	Control Arm
Arm/Group Description	Includes 4 components: Patient Education and Behavioral Activation by a Care Coordinator; Supporting Self-Care; Psychiatrist and Diabetologist Reviews; and Decision-support Electronic Health Record System	Will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The control participants only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor.
Measure Participants	196	208
BP 12 months -Post-intervention	71.9	73.8
BP 24 months -Post-intervention	74.6	77.0
BP 36 months -Post-intervention	63.4	73.7

11. Secondary Outcome

Title	Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Lipid Control
Description	Proportion of participants achieving treatment targets or significant reductions of lipid control: LDL ≤ 100 mg/dl or ≥ 10mg/dl reduction at 12, 24 and 36 months post-intervention. Greater proportion of participants achieving this target, correlates with better outcome.
Time Frame	12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Program of Care	Control Arm
Arm/Group Description	Includes 4 components: Patient Education and Behavioral Activation by a Care Coordinator; Supporting Self-Care; Psychiatrist and Diabetologist Reviews; and Decision-support Electronic Health Record System	Will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The control participants only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor.
Measure Participants	196	208
Lipid Control 12 months -Post-intervention	72.6	69.8
Lipid Control 24 months -Post-intervention	66.9	66.5
Lipid Control 36 months -Post-intervention	49.7	56.4

12. Secondary Outcome

Title	Mean Treatment Satisfaction Scores
Description	Mean charges in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) in the intervention and usual care groups. Score range is 0-6. Higher score is associated with better outcome.
Time Frame	12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Program of Care	Control Arm
Arm/Group Description	Includes 4 components: Patient Education and Behavioral Activation by a Care Coordinator; Supporting Self-Care; Psychiatrist and Diabetologist Reviews; and Decision-support Electronic Health Record System	Will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The control participants only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor.
Measure Participants	196	208
24 months -Post-intervention	2.22	1.16
36 months -Post-intervention	3.43	3.45

13. Secondary Outcome

Title	Mean Health Expenditures (Direct Medical Costs)
Description	Mean of direct medical costs for consultations, diagnostic tests, medications, hospital admissions, and/or surgeries or procedures) among participants in the treatment and usual care groups.
Time Frame	12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Program of Care	Control Arm
Arm/Group Description	Includes 4 components: Patient Education and Behavioral Activation by a Care Coordinator; Supporting Self-Care; Psychiatrist and Diabetologist Reviews; and Decision-support Electronic Health Record System	Will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The control participants only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor.
Measure Participants	196	208
Cost at 12 months -Post-intervention	23423.70 (11111.54)	8674.35 (6026.47)
Cost at 24 months -Post-intervention	32119.20 (14371.06)	17957.99 (10813.52)
Cost at 36 months -Post-intervention	41808.22 (17848.54)	28242.58 (15241.46)

14. Secondary Outcome

Title	Cost Utility in the Treatment Arm and Usual Care Arms
Description	The ratio of total costs, which include health expenditures by participants plus clinic or study costs to deliver the intervention and the relative gain or loss in health utilities (measured by the health utilities index). The within-trial cost-utility of intervention was compared to usual care, an incremental cost-utility ratio will be calculated [net costs to net utility: costs(intervention) - costs(control) / utility(intervention) - utility(control)]. The chosen measure of utility is the closest option to a global measure, the quality adjusted life year [QALY] and is calculated as the sum of mean survival time [life years] x utility scores at 6, 12, 18, 24 and 36 months.
Time Frame	12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)

Outcome Measure Data

Analysis Population Description

Results analyzed at 24 and 36 months post-intervention. Cost Utility was not collected at 12 months post-intervention.

Arm/Group Title	Incremental Cost Utility Ratio
Arm/Group Description	Includes participants in both study groups: Intervention and Control group
Measure Participants	404
Health utilities index at 24 months post-intervention	155,106.5
Health utilities index at 36 months post-intervention	121,993.2

Adverse Events

Time Frame	24 months post-intervention
Arm/Group Title	Intervention Program of Care		Control Arm
Arm/Group Description	Includes 4 components: Patient Education and Behavioral Activation by a Care Coordinator; Supporting Self-Care; Psychiatrist and Diabetologist Reviews; and Decision-support Electronic Health Record System		Will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The control participants only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor.
All Cause Mortality
	Intervention Program of Care		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/196 (1%)		7/208 (3.4%)
Serious Adverse Events
	Intervention Program of Care		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/196 (0%)		0/208 (0%)
Other (Not Including Serious) Adverse Events
	Intervention Program of Care		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/196 (0%)		0/208 (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.