Effectiveness of an mHealth-Based Electronic Decision Support System for Integrated Management of Chronic Conditions in Primary Care: The mWellcare Cluster-Randomized Controlled Trial
Effectiveness of an mHealth-Based Electronic Decision Support System for Integrated Management of Chronic Conditions in Primary Care: The mWellcare Cluster-Randomized Controlled Trial
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DOI：
10.1161/circulationaha.118.038192
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发表时间：
2019-01-15
期刊：
影响因子：
37.8
通讯作者：
Patel, Vikram
中科院分区：
文献类型：
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作者：
Prabhakaran, Dorairaj;Jha, Dilip;Patel, Vikram
背景：非传染性疾病及其风险因素的负担在全球范围内迅速增加，包括在印度。在一项涉及40个社区卫生中心的前瞻性、多中心、开放标签、整群随机对照试验中，我们以高血压和糖尿病为切入点，评估了mWellcare的有效性。mWellcare是一个由电子健康记录存储和电子决策支持组成的mHealth系统，用于综合管理5种慢性病(高血压、糖尿病、当前烟酒使用和抑郁症)，与加强常规护理相比，我们评估了mWellcare的有效性。在试验结束时(12个月的随访)，使用意向治疗分析，我们检查了ARMS之间作为主要结果的收缩压和糖化血红蛋白变化的平均差异，以及作为次要结果的空腹血糖、总胆固醇、预测的10年心血管疾病风险、抑郁评分以及报告吸烟和酒精使用的比例。结果：在40个分组的3698名登记参与者中(平均年龄55.1岁；SD，11岁；55.2%的男性)，3324人完成了试验。即使在调整了几个关键变量(调整后的收缩压差：-0.31[95%CI，-3.91至3.29]；糖化血红蛋白：0.08[95%CI，-0.27至0.44])后，两组患者的收缩压(=-0.98；95%CI，-4.64至2.67)和糖化血红蛋白(=0.11；95%CI，-0.24至0.45)也没有差异。MWellcare和加强常规护理的组内平均收缩压变化分别为-13.65 mm Hg和-12.66 mm Hg，糖化血红蛋白的平均收缩压变化分别为-0.48%和-0.58%。同样，在吸烟和饮酒或其他次要结果方面，两组之间的变化没有差异。结论：在所研究的慢性病的管理方面，我们没有发现mWellcare比加强的常规护理有增加的好处。临床试验注册：网址：https://www.clinicaltrials.gov.唯一标识：NCT02480062。
Background: The burden of noncommunicable diseases and their risk factors has rapidly increased worldwide, including in India. Innovative management strategies with electronic decision support and task sharing have been assessed for hypertension, diabetes mellitus, and depression individually, but an integrated package for multiple chronic condition management in primary care has not been evaluated.Methods: In a prospective, multicenter, open-label, cluster-randomized controlled trial involving 40 community health centers, using hypertension and diabetes mellitus as entry points, we evaluated the effectiveness of mWellcare, an mHealth system consisting of electronic health record storage and an electronic decision support for the integrated management of 5 chronic conditions (hypertension, diabetes mellitus, current tobacco and alcohol use, and depression) versus enhanced usual care among patients with hypertension and diabetes mellitus in India. At trial end (12-month follow-up), using intention-to-treat analysis, we examined the mean difference between arms in change in systolic blood pressure and glycated hemoglobin as primary outcomes and fasting blood glucose, total cholesterol, predicted 10-year risk of cardiovascular disease, depression score, and proportions reporting tobacco and alcohol use as secondary outcomes. Mixed-effects regression models were used to account for clustering and other confounding variables.Results: Among 3698 enrolled participants across 40 clusters (mean age, 55.1 years; SD, 11 years; 55.2% men), 3324 completed the trial. There was no evidence of difference between the 2 arms for systolic blood pressure (=-0.98; 95% CI, -4.64 to 2.67) and glycated hemoglobin (=0.11; 95% CI, -0.24 to 0.45) even after adjustment of several key variables (adjusted differences for systolic blood pressure: - 0.31 [95% CI, -3.91 to 3.29]; for glycated hemoglobin: 0.08 [95% CI, -0.27 to 0.44]). The mean within-group changes in systolic blood pressure in mWellcare and enhanced usual care were -13.65 mmHg versus -12.66 mmHg, respectively, and for glycated hemoglobin were -0.48% and -0.58%, respectively. Similarly, there were no differences in the changes between the 2 groups for tobacco and alcohol use or other secondary outcomes.Conclusions: We did not find an incremental benefit of mWellcare over enhanced usual care in the management of the chronic conditions studied.Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02480062.