A village doctor-led mobile health intervention for cardiovascular risk reduction in rural China: cluster randomised controlled trial.

Methods

Cluster randomised controlled trial.

群组随机对照试验。

127 villages from five provinces and autonomous regions in China.

127个村庄来自中国的五个省份和自治区。

4533 participants from 127 villages: 2297 (64 villages) were randomly assigned to the intervention group and 2236 (63 villages) to the control group.

来自127个村庄的4533名参与者：2297名（64个村庄）被随机分配到干预组，2236名（63个村庄）被分配到对照组。

Participants were aged ≥35 years, had no established atherosclerotic cardiovascular disease (ASCVD) but a predicted 10 year risk of ≥10%, had contracted a family doctor service with the local village doctor, and owned a smart phone.

参与者年龄≥35岁，没有确立的动脉粥样硬化性心血管疾病（ASCVD），但预测的10年风险≥10%，已经与当地村医签约家庭医生服务，并拥有智能手机。

In addition to usual clinical care and basic public health services provided for the control group, the intervention led by village doctors included five components: assessing risk factors to identify individualised intervention targets, setting gradual goals based on doctor-participant communication, providing targeted short videos on health education, conducting health monitoring with periodic feedback, and providing motivation to reduce risk based on gamification.

除了为对照组提供的常规临床护理和基础公共卫生服务外，由村医领导的干预措施包括五个部分：评估风险因素以确定个体化的干预目标，根据医患沟通设定逐步目标，提供针对性的健康教育短视频，进行健康监测并定期反馈，以及基于游戏化提供降低风险的动机。

main_outcome_measure

Mean change in predicted 10 year risk of ASCVD from baseline to 12 months.

从基线到12个月预测的10年动脉粥样硬化性心血管疾病（ASCVD）风险平均变化。

Results

Enrolment took place between March 2023 and May 2023.

招募工作发生在2023年3月至2023年5月之间。

During the 12 month follow-up (completion rate 99.4%), the 10 year risk of ASCVD decreased from 18.0% to 11.7% in the intervention group and from 17.8% to 13.6% in the control group (absolute difference -1.88% (95% confidence interval(CI) -2.57% to -1.19%; P<0.001).

在12个月的随访期间（完成率为99.4%），干预组的10年ASCVD风险从18.0%降低到11.7%，对照组从17.8%降低到13.6%（绝对差异为-1.88%（95%置信区间（CI）为-2.57%至-1.19%；P<0.001）。

Compared with the control group, the intervention group showed larger reductions in lifetime ASCVD risk (-15.9% v -11.0%; difference -4.59%; P<0.001), systolic blood pressure (-23.2 mm Hg v -15.2 mm Hg; difference -7.64 mm Hg; P<0.001), diastolic blood pressure (-10.9 mm Hg v -6.9 mm Hg; difference: -3.59 mm Hg; P<0.001), fasting blood glucose (-0.9 mmol/L v -0.5 mmol/L; difference -0.30 mmol/L; P=0.008), proportion of daily smokers (-3.1% v -0.6%; odds ratio 0.60, 95% CI 0.43 to 0.84; P=0.003), and insufficient physical activity (-3.0% v 1.3%; odds ratio 0.63, 0.42 to 0.95; P=0.03).

与对照组相比，干预组在终身ASCVD风险（-15.9%对比-11.0%；差异-4.59%；P<0.001）、收缩压（-23.2毫米汞柱对比-15.2毫米汞柱；差异-7.64毫米汞柱；P<0.001）、舒张压（-10.9毫米汞柱对比-6.9毫米汞柱；差异-3.59毫米汞柱；P<0.001）、空腹血糖（-0.9毫摩尔/升对比-0.5毫摩尔/升；差异-0.30毫摩尔/升；P=0.008）、每日吸烟者比例（-3.1%对比-0.6%；优势比0.60，95%置信区间0.43至0.84；P=0.003）以及不足的体力活动（-3.0%对比1.3%；优势比0.63，95%置信区间0.42至0.95；P=0.03）方面显示出更大的降低幅度。

No significant differences were observed for change in non-high density lipoprotein cholesterol or proportion of participants with obesity.

未观察到非高密度脂蛋白胆固醇变化或肥胖参与者比例的显著差异。

Conclusions

The village doctor-led mobile health intervention was effective at reducing cardiovascular risk and improving control of behavioural and metabolic risk factors.

由乡村医生领导的移动健康干预在降低心血管风险和改善行为及代谢风险因素控制方面是有效的。

This feasible approach could be scaled up in rural China and other under-resourced settings to improve health management based on the local primary healthcare system.

这种可行的方法可以在中国的农村和其他资源匮乏的环境中扩大规模，以基于当地的初级卫生保健系统改善健康管理。

trial_registration

ClinicalTrials.gov NCT05645640.

ClinicalTrials.gov NCT05645640。