Abstract
To develop a care model for patients with both diabetes and depression and assess the model's effectiveness. 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. 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. 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.
Published Version
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