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 A1c (HbA1c) 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 HbA1c, 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 (HbA1c <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 HbA1c, ≥5-mm Hg reduction in SBP, ≥10-mg/dL reduction in LDL cholesterol); percentage of patients who met all HbA1c, SBP, and LDL cholesterol targets; and mean reductions in SCL-20 score, Patient Health Questionnaire-9 score, HbA1c, 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. Trial Registration ClinicalTrials.gov Identifier: NCT02022111.

中文翻译：

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协作护理模式对印度抑郁症和糖尿病患者的抑郁症状和糖化血红蛋白、血压和血清胆固醇的影响

重要性 精神健康合并症在全球范围内不断增加并恶化糖尿病患者的预后，尤其是在护理分散的情况下。目的 评估协作护理与常规护理是否能降低糖尿病和抑郁症成人的抑郁症状并改善心脏代谢指数。设计、设置和参与者 在印度 4 个社会经济多样化的诊所进行的平行、开放标签、实用的随机临床试验，招募了 2 型糖尿病患者；患者健康问卷 - 9 得分至少为 10（范围，0-27）；血红蛋白 A1c (HbA1c) 至少为 8%，收缩压 (SBP) 至少为 140 mmHg，或低密度脂蛋白 (LDL) 胆固醇至少为 130 mg/dL。首例患者于2015年3月9日入组，最后一名患者于2016年5月31日入组；最后一次随访时间为 2018 年 7 月 14 日。 干预 随机分配到干预组的患者（n = 196）接受了非医师护理协调员 12 个月的自我管理支持、决策支持电子健康记录以促进医师治疗调整和专科病例评论；他们在没有干预的情况下又被随访了 12 个月。对照组的患者（n = 208）接受了 24 个月的常规护理。主要结果和测量 主要结果是 24 个月时症状检查表抑郁量表 (SCL-20) 评分（范围，0-4；分数越高表明该评分降低至少 50%）的患者百分比的组间差异更严重的症状）和 HbA1c 降低至少 0.5 个百分点，SBP 降低 5 mmHg，或 LDL 胆固醇降低 10 mg/dL。预设的次要结局是在 12 个月和 24 个月时达到治疗目标（HbA1c <7.0%，SBP <130 mmHg，LDL 胆固醇 <100 mg/dL [<70 mg/dL，如果既往心血管疾病]）或有改善的患者百分比在个体结果中（SCL-20 评分降低≥50%，HbA1c 降低≥0.5 个百分点，SBP 降低≥5 毫米汞柱，LDL 胆固醇降低≥10 毫克/分升）；达到所有 HbA1c、SBP 和 LDL 胆固醇目标的患者百分比；SCL-20 评分、患者健康问卷 9 评分、HbA1c、SBP 和 LDL 胆固醇的平均降低。结果 在随机分配的 404 名患者（平均 [SD] 年龄，53 [8.6] 岁；165 [40.8%] 名男性）中，378 名 (93.5%) 完成了试验。与常规护理组相比，干预组中达到主要结局的患者百分比明显更高（71.6% 对 57.4%；风险差异，16.9% [95% CI，8.5%-25.2%]）。在 16 项预先指定的次要结局中，12 个月时的 10 项结局和 24 个月时的 13 项结局在改善方面没有统计学显着的组间差异。干预组和常规护理组的严重不良事件包括心血管事件或住院（4 [2.0%] vs 7 [3.4%]）、中风（0 vs 3 [1.4%]）、死亡（2 [1.0%] vs 7 [ 3.4%]）和严重低血糖（8 [4.1%] vs 0）。结论和相关性 在印度的糖尿病和抑郁症患者中，与常规护理相比，为期 12 个月的协作护理干预导致 24 个月时抑郁症状和心脏代谢指数的综合测量出现统计学显着改善。需要进一步研究以了解研究结果对其他中低收入医疗保健环境的普遍性。试验注册 ClinicalTrials.gov 标识符：NCT02022111。