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

作者：Kowalski A J; Poongothai S; Chwastiak L; Hutcheson M; Tandon N; Khadgawat R; Sridhar G R; Aravind S R; Sosale B; Anjana R M; Rao D; Sagar R; Mehta N; Narayan K M V; Unutzer J; Katon W; Mohan V; Ali M K^*

来源：Contemporary Clinical Trials, 2017, 60: 113-124.

DOI：10.1016/j.cct.2017.06.013

• Depression
• Diabetes
• Collaborative care
• Decision support
• Healthcare delivery

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 >= 140 mm Hg, and/or LDL >= 130 mg/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 HbAl c, >= 5 mm Hg reduction in SBP, or >= 10 mg/dl reduction in LDL-c at 24 months (12-month intervention; 12-month observational followup). 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 clinics in India

• 出版日期2017-9
• 单位河北医科大学