Randomized Controlled Trial Testing the Efficacy of an mHealth Application to Reduce Risk Factors for the Primary Prevention of Stroke.

Methods

This phase III, prospective, outcome assessor-blinded, 2-arm randomized controlled trialin Australia and New Zealand recruited participants from August 2021 to January 2024.

这项在澳大利亚和新西兰进行的第三阶段、前瞻性、评估者盲法、两臂随机对照试验，招募参与者的时间为2021年8月至2024年1月。

Inclusion criteria: age ≥35 and ≤75 years; ≥2 risk factors; smartphone ownership; and no cardiovascular disease history.

纳入标准：年龄≥35岁且≤75岁；≥2个风险因素；拥有智能手机；且无心血管疾病史。

The intervention group was given access to the application; the usual care group received one email with generic risk factor information.

干预组获得了应用程序的访问权限；常规护理组收到了一封包含一般风险因素信息的电子邮件。

The primary outcome was the mean between-group difference in Life's Simple 7 (score 0 [poor] to 14 [ideal], comprising blood pressure, cholesterol, glucose, body mass index, smoking, and physical activity and diet) from baseline to 6 months postrandomization.

主要结果是随机化后6个月内两组间Life's Simple 7平均组间差异（评分范围从0[差]到14[理想]，包括血压、胆固醇、血糖、体重指数、吸烟以及体力活动和饮食），从基线开始计算。

Secondary outcomes were between-group changes in individual Life's Simple 7 items.

次要结果是各Life's Simple 7项目在两组间的组间变化。

Analyses were performed using intention-to-treatprinciples with ANCOVA and linear mixed models to examine differences between groups, with prespecified per-protocol and subgroup analyses.

使用意向治疗原则进行分析，采用协方差分析和线性混合模型来检查组间差异，预先设定的按方案和亚组分析。

Results

We randomized 862 participants (mean±SD age, 58±11 years; 63% women; 74% White).

我们随机分配了862名参与者（平均年龄±标准差为58±11岁；63%为女性；74%为白人）。

At 6 months postrandomization in intention-to-treatanalyses, the mean difference between usual care (n=433) and intervention (n=429) groups in the change in Life's Simple 7 score from baseline was 0.03 ([95% CI, -0.19 to 0.25]; P=0.788).

在随机化后6个月的意向治疗分析中，常规护理组（n=433）和干预组（n=429）在从基线开始的Life's Simple 7评分变化的平均差异为0.03（[95% 置信区间, -0.19至0.25]；P=0.788）。

Per-protocol analyses (n=320 usual care; n=276 intervention) were similar (mean difference in change, 0.20 [95% CI, -0.04 to 0.43]; P=0.106).

按方案分析（n=320常规护理；n=276干预）结果相似（变化的平均差异为0.20 [95% 置信区间, -0.04至0.43]；P=0.106）。

Compared with usual care in intention-to-treatanalyses, the intervention group had a nonsignificant increase in metabolic equivalent of task (metabolic equivalent of task) minutes per week of physical activity (313.42 [95% CI, -2.80 to 629.65]; P=0.052), with no differences in other Life's Simple 7 items.

与常规护理意向治疗分析相比，干预组每周体力活动的代谢当量（MET）分钟数有非显著性增加（313.42 [95% 置信区间, -2.80至629.65]; P=0.052），其他Life's Simple 7项目没有差异。

Conclusions

Among a general population aged 35 years to 75 years with ≥2 stroke risk factors, there was no evidence that having access to the application changed overall Life's Simple 7 scores at 6-month follow-up.

在年龄在35岁至75岁之间，具有≥2个中风风险因素的普通人群中，没有证据表明在6个月随访时，使用应用程序改变了整体Life's Simple 7评分。

Participants in the intervention group did have a nonsignificant increase in physical activity, compared with the usual care group, after 6 months, but not in other individual risk factors.

干预组参与者在6个月后与常规护理组相比，体力活动确实有所增加，但其他个别风险因素并未显著改善。

registration

URL: https://www.anzctr.org.au/; Unique identifier: ACTRN12621000211864.

网址: https://www.anzctr.org.au/; 唯一标识符: ACTRN12621000211864。