INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) Study

NCT02022111 | Completed Results DMC

• 2 other identifiers: IRB00064913R01MH100390-01
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 4

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.

Conditions

Diabetes; Depression; Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (1)

• Percentage of Combined Improvement of Depressive Symptoms and CVD Risk Factors

  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).

  24-months post-intervention

Secondary Outcomes (13)

• Measures of "Common Effect"

  12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Intervention Program of Care

ACTIVE COMPARATOR

1. Patient Education and Behavioral Activation by a Care Coordinator; 2. Supporting Self-Care; 3. Psychiatrist and Diabetologist Reviews; and 4. Decision-support Electronic Health Record System

Behavioral: Patient Education and Behavioral Activation; Behavioral: Supporting Self-Care (care coordinators); Other: Psychiatrist and Diabetologist Reviews; Other: Decision-support Electronic Health Record System

Control Arm

PLACEBO COMPARATOR

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

Interventions

Patient Education and Behavioral Activation BEHAVIORAL

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.

Intervention Program of Care

Supporting Self-Care (care coordinators) BEHAVIORAL

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.

Intervention Program of Care

Psychiatrist and Diabetologist Reviews OTHER

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.

Intervention Program of Care

Decision-support Electronic Health Record System OTHER

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).

Intervention Program of Care

Standard of Care OTHER

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.

Control Arm

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (4)

Diacon Hospital, Diabetes Care and Research Center

Bangalore, India

Location

Madras Diabetes Research Foundation

Chennai, India

Location

All India Institute of Medical Sciences

Delhi, India

Location

Endocrine Diabetes Center

Visakhapatnam, India

Location

Related Publications (9)

• 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.

  PMID: 2698445 BACKGROUND

• Detsky AS, Naglie IG. A clinician's guide to cost-effectiveness analysis. Ann Intern Med. 1990 Jul 15;113(2):147-54. doi: 10.7326/0003-4819-113-2-147.

  PMID: 2113784 BACKGROUND

• 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.

  PMID: 21190455 BACKGROUND

• 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.

  PMID: 23084280 BACKGROUND

• Halliday S, Rao D, Augusto O, Poongothai S, Sosale A, Sridhar GR, Tandon N, Sagar R, Patel SA, Narayan KMV, Johnson LCM, Wagenaar BH, Huh D, Flaherty BP, Chwastiak LA, Ali MK, Mohan V; INDEPENDENT Study Group. A mediation analysis evaluating change in self-stigma on diabetes outcomes among people with depression in urban India: A secondary analysis from the INDEPENDENT trial of the collaborative care model. PLOS Glob Public Health. 2024 Sep 4;4(9):e0003624. doi: 10.1371/journal.pgph.0003624. eCollection 2024.

  PMID: 39231130 DERIVED

• Hassan S, Liu S, Johnson LCM, Patel SA, Emmert-Fees KMF, Suvada K, Tandon N, Sridhar GR, Aravind S, Poongothai S, Anjana RM, Mohan V, Chwastiak L, Ali MK. Association of collaborative care intervention features with depression and metabolic outcomes in the INDEPENDENT study: A mixed methods study. Prim Care Diabetes. 2024 Jun;18(3):319-326. doi: 10.1016/j.pcd.2024.02.001. Epub 2024 Feb 15.

  PMID: 38360505 DERIVED

• Suvada K, Ali MK, Chwastiak L, Poongothai S, Emmert-Fees KMF, Anjana RM, Sagar R, Shankar R, Sridhar GR, Kasuri M, Sosale AR, Sosale B, Rao D, Tandon N, Narayan KMV, Mohan V, Patel SA. Long-term Effects of a Collaborative Care Model on Metabolic Outcomes and Depressive Symptoms: 36-Month Outcomes from the INDEPENDENT Intervention. J Gen Intern Med. 2023 May;38(7):1623-1630. doi: 10.1007/s11606-022-07958-8. Epub 2023 Jan 3.

  PMID: 36596908 DERIVED

• Ali MK, Chwastiak L, Poongothai S, Emmert-Fees KMF, Patel SA, Anjana RM, Sagar R, Shankar R, Sridhar GR, Kosuri M, Sosale AR, Sosale B, Rao D, Tandon N, Narayan KMV, Mohan V; INDEPENDENT Study Group. Effect of a Collaborative Care Model on Depressive Symptoms and Glycated Hemoglobin, Blood Pressure, and Serum Cholesterol Among Patients With Depression and Diabetes in India: The INDEPENDENT Randomized Clinical Trial. JAMA. 2020 Aug 18;324(7):651-662. doi: 10.1001/jama.2020.11747.

  PMID: 32809002 DERIVED

• Kowalski AJ, Poongothai S, Chwastiak L, Hutcheson M, Tandon N, Khadgawat R, Sridhar GR, Aravind SR, Sosale B, Anjana RM, Rao D, Sagar R, Mehta N, Narayan KMV, Unutzer J, Katon W, Mohan V, Ali MK. The INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) study: Design and methods to address mental healthcare gaps in India. Contemp Clin Trials. 2017 Sep;60:113-124. doi: 10.1016/j.cct.2017.06.013. Epub 2017 Jun 19.

  PMID: 28642211 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Depression

Interventions

Patient Education as Topic; Psychiatrists; Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Physicians; Health Personnel; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Mohammed Kumail Ali, MD
• Organization: Emory University

mkali@emory.edu

404-727-9776

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: December 27, 2013
• Study Start: March 1, 2014
• Primary Completion: July 14, 2018
• Study Completion: September 27, 2019
• Last Updated: May 3, 2021
• Results First Posted: May 14, 2020

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (4)