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 effectiveness.
RESEARCH DESIGN AND METHODS
In this pragmatic cluster-randomized trial, we allocated 8 community health centers into two groups: enhanced usual care and intervention group. In the intervention group, a comprehensive care plan was developed based on the integrated care model. We recruited individuals aged 18 years or older with type 2 diabetes and depression (PHQ-9 ≥ 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. We performed the outcome analysis within the intention-to-treat population, with missing data being multiply imputed.
RESULTS
We enrolled 630 participants, with 275 in intervention group and 355 in control group. We observed significant greater percentage of patients in the intervention group who met the primary outcome at 12 months (depressive symptoms: risk difference (RD) 31.03% [62.06% vs. 31.02%, 95% CI = 21.85%-40.21%], HbA1c: RD 19.16%, [32.41% vs. 13.25%, 95% CI = 11.35% to 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, 95% CI = 3.75-9.74]), diabetes self-care activities (MD 0.69 [3.46 vs. 2.78, 95% CI = 0.52-0.86]), medication adherence (MD 0.72 [6.49 vs. 5.78, 95% CI = 0.37-1.07]) and experience of care MD 0.89 [3.84 vs. 2.95, 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 in the identification and management of patients with physical and mental multimorbidity in primary healthcare settings.