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.

Importance Mental health comorbidities are increasing worldwide and worsen outcomes for people with diabetes, especially when care is fragmented. Objective To assess whether collaborative care vs usual care lowers depressive symptoms and improves cardiometabolic indices among adults with diabetes and depression. Design, Setting, and Participants Parallel, open-label, pragmatic randomized clinical trial conducted at 4 socioeconomically diverse clinics in India that recruited patients with type 2 diabetes; a Patient Health Questionnaire-9 score of at least 10 (range, 0-27); and hemoglobin A(1c)(HbA(1c)) of at least 8%, systolic blood pressure (SBP) of at least 140 mm Hg, or low-density lipoprotein (LDL) cholesterol of at least 130 mg/dL. The first patient was enrolled on March 9, 2015, and the last was enrolled on May 31, 2016; the final follow-up visit was July 14, 2018. Interventions Patients randomized to the intervention group (n = 196) received 12 months of self-management support from nonphysician care coordinators, decision support electronic health records facilitating physician treatment adjustments, and specialist case reviews; they were followed up for an additional 12 months without intervention. Patients in the control group (n = 208) received usual care over 24 months. Main Outcomes and Measures The primary outcome was the between-group difference in the percentage of patients at 24 months who had at least a 50% reduction in Symptom Checklist Depression Scale (SCL-20) scores (range, 0-4; higher scores indicate worse symptoms) and a reduction of at least 0.5 percentage points in HbA(1c), 5 mm Hg in SBP, or 10 mg/dL in LDL cholesterol. Prespecified secondary outcomes were percentage of patients at 12 and 24 months who met treatment targets (HbA(1c)<7.0%, SBP <130 mm Hg, LDL cholesterol <100 mg/dL [<70 mg/dL if prior cardiovascular disease]) or had improvements in individual outcomes (>= 50% reduction in SCL-20 score, >= 0.5-percentage point reduction in HbA(1c), >= 5-mm Hg reduction in SBP, >= 10-mg/dL reduction in LDL cholesterol); percentage of patients who met all HbA(1c), SBP, and LDL cholesterol targets; and mean reductions in SCL-20 score, Patient Health Questionnaire-9 score, HbA(1c), SBP, and LDL cholesterol. Results Among 404 patients randomized (mean [SD] age, 53 [8.6] years; 165 [40.8%] men), 378 (93.5%) completed the trial. A significantly greater percentage of patients in the intervention group vs the usual care group met the primary outcome (71.6% vs 57.4%; risk difference, 16.9% [95% CI, 8.5%-25.2%]). Of 16 prespecified secondary outcomes, there were no statistically significant between-group differences in improvements in 10 outcomes at 12 months and in 13 outcomes at 24 months. Serious adverse events in the intervention and usual care groups included cardiovascular events or hospitalizations (4 [2.0%] vs 7 [3.4%]), stroke (0 vs 3 [1.4%]), death (2 [1.0%] vs 7 [3.4%]), and severe hypoglycemia (8 [4.1%] vs 0). Conclusions and Relevance Among patients with diabetes and depression in India, a 12-month collaborative care intervention, compared with usual care, resulted in statistically significant improvements in a composite measure of depressive symptoms and cardiometabolic indices at 24 months. Further research is needed to understand the generalizability of the findings to other low- and middle-income health care settings.This randomized clinical trial compares the effect of a collaborative care model that integrates management of depression and enhanced diabetes care on depressive symptoms and HbA(1c), SBP, and LDL cholesterol measures among individuals with depression and diabetes in India.Question Among patients with diabetes and depression in India, does a 12-month collaborative care intervention that includes nonphysician care coordinators, decision support functions in electronic health records, and specialist case reviews improve depressive symptoms and measures of cardiometabolic health more than usual care at 24 months? Findings In this randomized clinical trial that included 404 patients at urban clinics in India with poorly controlled diabetes and depression, patients in the collaborative care intervention group, compared with the usual care group, were significantly more likely to achieve the composite outcome of at least a 50% reduction in the 20-item Symptom Checklist Depression Scale score and at least 1 of the following: reduction of at least 0.5 percentage points in hemoglobin A(1c), reduction of at least 5 mm Hg in systolic blood pressure, or reduction of at least 10 mg/dL in low-density lipoprotein cholesterol at 24 months (71.6% vs 54.7%). Meaning Among patients with diabetes and depressive symptoms in urban India, a multicomponent collaborative care intervention resulted in statistically significantly greater improvements in a composite measure of depressive symptoms and cardiometabolic indices compared with usual care