Effect of Community-Based Integrated Care for Patients With Diabetes and Depression (CIC-PDD) in China: A Pragmatic Cluster-Randomized Trial

OBJECTIVE To develop a care model for patients with both diabetes and depression and assess the model’s effectiveness. RESEARCH DESIGN AND METHODS In this pragmatic cluster randomized trial, we allocated eight community health centers into two groups: the enhanced usual care group and the intervention group. A comprehensive care plan was developed for the intervention group based on the integrated care model. We recruited individuals aged ≥18 years with type 2 diabetes and depression (Patient Health Questionnaire-9 score ≥10). The primary outcome was the between-group difference in the percentage of patients who had at least a 50% reduction in depressive symptoms and a reduction of at least 0.5 percentage points in HbA1c. The outcome analysis was conducted within the intention-to-treat population; missing data were multiply imputed. RESULTS We enrolled 630 participants, with 275 in the intervention group and 355 in the control group. A significantly greater percentage of patients in the intervention group met the primary outcome at 12 months (for depressive symptoms: risk difference [RD] 31.03% [62.06% vs. 31.02%, respectively; 95% CI 21.85–40.21]; for HbA1c: RD 19.16% [32.41% vs. 13.25%, respectively; 95% CI 11.35–26.97]). The patients in the intervention group showed significant enhancements in mental quality of life (mean difference [MD] 6.74 [46.57 vs. 39.83, respectively; 95% CI 3.75–9.74]), diabetes self-care activities (MD 0.69 [3.46 vs. 2.78, respectively; 95% CI 0.52–0.86]), medication adherence (MD 0.72 [6.49 vs. 5.78, respectively; 95% CI 0.37–1.07]), and experience of care (MD 0.89 [3.84 vs. 2.95, respectively; 95% CI 0.65–1.12]) at 12 months. Rural participants benefited more from the intervention. CONCLUSIONS The implementation strategy can serve as a valuable blueprint for the identification and treatment of patients with physical and mental multimorbidity in primary health care settings.