The INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) study: Design and methods to address mental healthcare gaps in India

Abstract

Introduction Depression and diabetes are highly prevalent worldwide and often co-exist, worsening outcomes for each condition. Barriers to diagnosis and treatment are exacerbated in low and middle-income countries with limited health infrastructure and access to mental health treatment. The INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) study tests the sustained effectiveness and cost-effectiveness of a multi-component care model for individuals with poorly-controlled diabetes and depression in diabetes clinics in India. Materials and Methods Adults with diabetes, depressive symptoms (Patient Health Questionnaire-9 score ≥10), and ≥1 poorly-controlled cardiometabolic indicator (either HbA1c ≥8.0%, SBP ≥140mmHg, and/or LDL ≥130mg/dl) were enrolled and randomized to the intervention or usual care. The intervention combined collaborative care, decision-support, and population health management. The primary outcome is the between-arm difference in the proportion of participants achieving combined depression response (≥50% reduction in Symptom Checklist score from baseline) AND one or more of: ≥0.5% reduction in HbA1c, ≥5 mmHg reduction in SBP, or ≥10 mg/dl reduction in LDL-c at 24 months (12-month intervention; 12-month observational follow-up). Other outcomes include control of individual parameters, patient-centered measures (i.e. treatment satisfaction), and cost-effectiveness. Results The study trained seven care coordinators. Participant recruitment is complete – 940 adults were screened, with 483 eligible, and 404 randomized (196 to intervention; 208 to usual care). Randomization was balanced across clinic sites. Conclusions The INDEPENDENT model aims to increase access to mental health care and improve depression and cardiometabolic disease outcomes among complex patients with diabetes by leveraging the care provided in diabetes clinics in India (clinicaltrials.gov number: NCT02022111).

Elements and Performance Indicators of Integrated Healthcare Programmes on Chronic Diseases in Six Countries in the Asia-Pacific Region: A Scoping Review

“…In our review, the enabling factors varied by specific context and study country. Many of the programmes identified in India clearly mentioned the success of programmes rested upon adapting them to the local context to ensure acceptability with the local staff and patients [ 33 34 35 ]. In Singapore, strong government involvement and leadership was frequently cited as a facilitator [ 36 37 38 ].…”

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Effectiveness of a Video-Based Lifestyle Education Program Compared to Usual Care in Improving HbA1c and Other Metabolic Parameters in Individuals with Type 2 Diabetes: An Open-Label Parallel Arm Randomized Control Trial (RCT)

“…Secondary outcome measurements were change in fasting plasma glucose (FPG), weight, body mass index (BMI), waist circumference, blood pressure, and lipid parameters. [12], and a delta of 0.5 between the intervention and usual care arm, the estimated sample size was 36 in each arm. The assumed power and alpha were 90% and 2.5%, respectively.…”

On psychology and psychiatry in diabetes

“…It was a longitudinal study assessing whether improvement of depression is associated with improved metabolic parameters and whether they would persist over time. [ 105 ] Funded by NIDDK NIH HHS, it was done in collaboration with Emory University, Georgia, University of Washington, Seattle (names of collaborators given in the references).…”