Clinical trial NCT02022111: INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) Study
Official title: INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Depression
Cardiovascular Risk Factor
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Washington
name: Madras Diabetes Research Foundation
name: All India Institute of Medical Sciences
name: Endocrine & Diabetes Centre
name: Diacon Hospital
First posted: 2013-12-27
Enrollment: 404
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Combined Improvement of Depressive Symptoms and CVD Risk Factors
timeFrame: 24-months post-intervention
Secondary outcomes:
measure: Measures of "Common Effect"
timeFrame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
measure: Proportion of Participants Achieving All 3 CVD Risk Factor Targets in the Two Groups
timeFrame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
measure: Mean Changes in Each of the Four Main Targets: SCL-20 Score
timeFrame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
measure: Mean Changes in Each of the Four Main Targets: HbA1c
timeFrame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
measure: Mean Changes in Each of the Four Main Targets: SBP
timeFrame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
measure: Mean Changes in Each of the Four Main Targets: LDL-c in mg/dl
timeFrame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
measure: Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: SCL-20
timeFrame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
measure: Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Glycemic Control
timeFrame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
measure: Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Blood Pressure
timeFrame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
measure: Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Lipid Control
timeFrame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
measure: Mean Treatment Satisfaction Scores
timeFrame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
measure: Mean Health Expenditures (Direct Medical Costs)
timeFrame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
measure: Cost Utility in the Treatment Arm and Usual Care Arms
timeFrame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Diacon Hospital, Diabetes Care and Research Center
city: Chennai
country: India
facility: Madras Diabetes Research Foundation
city: Delhi
country: India
facility: All India Institute of Medical Sciences
city: Visakhapatnam
country: India
facility: Endocrine Diabetes Center
Study officials:
affiliation: Dr Mohan's Diabetes Specialities Clinic
name: Viswanathan Mohan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Mohammed K Ali, MBChB, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Lydia Chwastiak, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.