基于移动健康的职业心血管风险干预研究（mHealth-OPEN研究）的设计、基本原理和特征

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal Pub Date : 2025-02-13 DOI:10.1016/j.ahj.2025.02.005

Yixin Tian PhD , Xin Wang MD , Zhen Hu PhD , Xue Yu MS , Min Shao MS , Chuanxi Zhang MS , Dedi Zhang MS , Wenping Shan MS , Chenye Chang MS , Chenda Zhang MS , Yuxuan Nie MS , Congyi Zheng PhD , Xue Cao PhD , Xuyan Pei PhD , Yujie Zhang MS , Nuerguli Tuerdi MS , Zengwu Wang PhD

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引用次数: 0

摘要

背景：大量的劳动力和不理想的心血管健康突出了工作场所干预措施的迫切需要。这项正在进行的集群随机试验旨在评估基于移动健康（mHealth）的综合干预计划的有效性、可行性和可接受性，以改善员工的心血管健康。方法和结果：我们在20个工作场所进行了一项为期一年的、双臂、平行组、集群随机对照多中心试验，涉及10,000名参与者（年龄在18至65岁之间，其中包括1,600名心血管高风险参与者）。工作场所按1:1的比例被随机分配到干预组或对照组。建立基于移动健康的多层次心血管风险管理系统，实现自动化、智能化管理。干预组接受基于移动健康的管理，对所有参与者进行初级预防发明，并通过系统对心血管高风险参与者进行额外的心血管风险干预。对照组接受常规护理。主要结局包括高血压、糖尿病和血脂异常控制率的百分比变化，以及所有参与者从基线到12个月随访期间定期体育活动率的百分比变化。次要结局包括血压、血糖、血脂、治疗依从性、问卷评分和治疗出现的不良事件的变化。到目前为止，基线招募已经完成，管理组和对照组的特征相当。结论：这种设计严谨的基于移动健康的工作场所干预显示出在全国范围内实施的潜力，为员工及其家人提供心血管益处。临床试验注册：www.chictr.org.cn。标识符:ChiCTR2200066196。

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Design, rationale, and characterization of the mobile health based occupational cardiovascular risk intervention study (mHealth-OPEN study)

Background

The substantial workforce and suboptimal cardiovascular health highlights the urgent need for workplace interventions. This ongoing cluster-randomized trial aims to evaluate the effectiveness, feasibility, and acceptability of a mobile health (mHealth) based comprehensive intervention program to improve cardiovascular health among employees.

Methods and results

We conducted a 1-year, 2-arm, parallel-group, cluster-randomized controlled multicenter trial involving 10,000 participants (aged 18-65, including 1,600 participants with high cardiovascular risk) across 20 workplaces. Workplaces were randomly assigned in a 1:1 ratio to either the intervention or control group. We established a mHealth based multifaceted cardiovascular risk management system that enables intelligent management. The intervention groups received a mHealth-based management with primary prevention inventions for all participants and additional cardiovascular risk interventions for participants with high cardiovascular risk via the system. The control groups received usual care. Primary outcomes included percentage changes in hypertension, diabetes, and dyslipidemia control rates among participants with high cardiovascular risk, and percentage changes in the rate of regular physical activity among all the participants, from baseline to 12-month follow-up. Secondary outcomes included changes in blood pressure, glucose, lipid, treatment adherence, behavioral factors, questionnaire scores, and incidence of major cardiovascular events. By now, baseline recruitment has been completed, with comparable characteristics between management and control groups.

Conclusions

This rigorous designed mHealth-based workplace intervention demonstrates potential for nationwide implementation, offering cardiovascular benefits for employees.

Clinical trial registration

www.chictr.org.cn. Identifier: ChiCTR2200066196.

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来源期刊

American heart journal 医学-心血管系统

CiteScore

8.20

自引率

2.10%

发文量

214

审稿时长

38 days

期刊介绍： The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.