Improving the management of type 2 diabetes in China using a multifaceted digital health intervention in primary health care: the SMARTDiabetes cluster randomised controlled trial

IF 7.6 1区 医学 Q1 HEALTH CARE SCIENCES & SERVICES The Lancet Regional Health: Western Pacific Pub Date : 2024-07-03 DOI:10.1016/j.lanwpc.2024.101130
Puhong Zhang , Xuanchen Tao , Yuxia Ma , Yaosen Zhang , Xinyan Ma , Hongyi Song , Yu Liu , Anushka Patel , Stephen Jan , David Peiris
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Abstract

Background

There is limited evidence, mainly from high-income countries, that digital health interventions improve type 2 diabetes (T2DM) care. Large-scale implementation studies are lacking.

Methods

A multifaceted digital health intervention comprising: (1) a self-management application (‘app’) for patients and lay ‘family health promotors’ (FHPs); and (2) clinical decision support for primary care doctors was evaluated in an open-label, parallel, cluster randomized controlled trial in 80 communities (serviced by a primary care facility for >1000 residents) in Hebei Province, China. People >40 years with T2DM and a glycated haemoglobin (HbA1c) ≥7% were recruited (∼25/community). After baseline assessment, community clusters were randomly assigned to intervention or control groups (1:1) via a web-based system, stratified by locality (rural/urban). Control arm clusters received usual care without access to the digital health application or family health promoters. The primary outcome was at the participant level defined as the proportion with ≥2 “ABC” risk factor targets achieved (HbA1c < 7.0%, blood pressure < 140/80 mmHg and LDL-cholesterol < 2.6 mmol/L) at 24 months.

Findings

A total of 2072 people were recruited from the 80 community clusters (40 urban and 40 rural), with 1872 (90.3%) assessed at 24 months. In the intervention arm, patients used FHPs for support more in rural than urban communities (252 (48.6%) rural vs 92 (21.5%) urban, p < 0.0001). The mean monthly proportion of active app users was 46.4% (SD 7.8%) with no significant difference between urban and rural usage rates. The intervention was associated with improved ABC control rates (339 [35.9%] intervention vs 276 [29.9%] usual care; RR 1.20, 95% CI 1.02–1.40; p = 0.025), with significant heterogeneity by geography (rural 220 [42.6%] vs 158 [31.0%]; urban 119 [27.9%] vs 118 [28.6%]; p = 0.022 for interaction). Risk factor reductions were mainly driven by improved glycaemic control (mean HbA1C difference −0.33%, 95% CI −0.48 to −0.17; p = 0.00025 and mean fasting plasma glucose difference −0.58 mmol, 95% CI −0.89 to −0.27; p = 0.00013). There were no changes in blood pressure and LDL-cholesterol levels.

Interpretation

A multifaceted digital health intervention improved T2DM risk factor control rates, particularly in rural communities where there may be stronger relationships between patients and doctors and greater family member support.

Funding

National Health and Medical Research Council Global Alliance for Chronic Diseases (ID 1094712).

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在中国初级卫生保健中采用多元数字健康干预措施改善 2 型糖尿病管理:SMARTDiabetes 群组随机对照试验
背景目前主要来自高收入国家的有限证据表明,数字健康干预能够改善2型糖尿病(T2DM)护理。方法在中国河北省的 80 个社区(由一个拥有 1000 名居民的初级保健机构提供服务)开展了一项开放标签、平行、分组随机对照试验,评估了多方面的数字健康干预措施,其中包括:(1)面向患者和非专业 "家庭健康促进者"(FHPs)的自我管理应用程序("应用程序");(2)面向初级保健医生的临床决策支持。试验招募了 40 岁以上患有 T2DM 且糖化血红蛋白(HbA1c)≥7% 的患者(25 人/社区)。基线评估后,通过网络系统,按地区(农村/城市)分层,将社区群组随机分配到干预组或对照组(1:1)。对照组群接受常规护理,不使用数字健康应用或家庭健康促进者。主要结果是在参与者层面,定义为在24个月时达到≥2个 "ABC "风险因素目标(HbA1c < 7.0%、血压 < 140/80 mmHg和低密度脂蛋白胆固醇 < 2.6 mmol/L)的比例。结果从80个社区集群(40个城市集群和40个农村集群)共招募了2072人,其中1872人(90.3%)在24个月时接受了评估。在干预组中,农村社区患者使用家庭保健计划寻求支持的比例高于城市社区(农村 252 人(48.6%)对城市 92 人(21.5%),P < 0.0001)。每月活跃应用程序用户的平均比例为 46.4%(标准差为 7.8%),城市和农村的使用率无显著差异。干预与 ABC 控制率的提高有关(339 [35.9%] 干预 vs 276 [29.9%] 常规护理;RR 1.20,95% CI 1.02-1.40;p = 0.025),不同地域之间存在显著的异质性(农村 220 [42.6%] vs 158 [31.0%];城市 119 [27.9%] vs 118 [28.6%];交互作用 p = 0.022)。风险因素的减少主要是由于血糖控制的改善(平均 HbA1C 差异为 -0.33%,95% CI 为 -0.48 至 -0.17;p = 0.00025;平均空腹血浆葡萄糖差异为 -0.58 mmol,95% CI 为 -0.89 至 -0.27;p = 0.00013)。多方面的数字健康干预提高了T2DM风险因素的控制率,尤其是在农村社区,因为那里的患者与医生之间的关系更密切,家庭成员的支持也更多。
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来源期刊
The Lancet Regional Health: Western Pacific
The Lancet Regional Health: Western Pacific Medicine-Pediatrics, Perinatology and Child Health
CiteScore
8.80
自引率
2.80%
发文量
305
审稿时长
11 weeks
期刊介绍: The Lancet Regional Health – Western Pacific, a gold open access journal, is an integral part of The Lancet's global initiative advocating for healthcare quality and access worldwide. It aims to advance clinical practice and health policy in the Western Pacific region, contributing to enhanced health outcomes. The journal publishes high-quality original research shedding light on clinical practice and health policy in the region. It also includes reviews, commentaries, and opinion pieces covering diverse regional health topics, such as infectious diseases, non-communicable diseases, child and adolescent health, maternal and reproductive health, aging health, mental health, the health workforce and systems, and health policy.
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