A Cluster-Randomized Trial of a Hypertension Risk Model-Based Precision Intervention in High-Risk Adults in Shunyi District
A Multicenter, Parallel-Group, Community Cluster-Randomized Controlled Trial of a Hypertension Risk Model-Based Precision Intervention for Adults at High Risk of Hypertension in Shunyi District, Beijing, China
研究概览
地位
条件
详细说明
This is a multicenter, parallel-group, community cluster-randomized controlled trial conducted in Shunyi District, Beijing, China. The trial includes four community clusters: Shuangxing South Community, Jianxin North Community, Houfengbo Village, and Hebei Village. The community cluster is the unit of randomization. The four clusters are allocated in a 1:1 ratio, with two clusters assigned to the precision intervention group (Shuangxing South Community and Houfengbo Village) and two clusters assigned to the control group (Jianxin North Community and Hebei Village). Individual participants are not separately randomized; eligible participants receive the intervention assigned to their community cluster.
Eligible residents are screened using a WeChat-based hypertension risk assessment program. Adults aged 35 to 65 years with a predicted hypertension risk greater than 20%, without a current diagnosis of hypertension and without current use of antihypertensive medication, are eligible for enrollment if all other eligibility criteria are met.
Participants in intervention clusters receive a hypertension risk model-based precision health management intervention. Following baseline risk assessment, community healthcare providers conduct an initial face-to-face or online visit within 5 to 15 days and develop an individualized health management plan. Follow-up is conducted at months 1, 3, and 6. Each follow-up focuses on the control or improvement of individual hypertension-related risk factors and lasts at least 15 minutes. The intervention also includes personalized health education, behavioral goal setting and tracking, health management tools, guidance on regular blood pressure monitoring, and referral to a hypertension specialist when clinically indicated.
Participants in control clusters receive standard health education materials, general non-personalized health information, routine quarterly health education, and usual community healthcare services.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Feng Sun, PhD
- 电话号码：+8613811155891
- 邮箱：sunfeng@bjmu.edu.cn
学习地点
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Beijing Municipality
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Beijing、Beijing Municipality、中国、101300
- 招聘中
- Shunyi District Center for Disease Control and Prevention, Beijing
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接触：
- Abiden Kapar, MM
- 电话号码：+8617690831880
- 邮箱：abiden@sina.com
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接触：
- Zhiqiang Feng, BD
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
Aged 35 to 65 years. Permanent resident of Shunyi District, Beijing, China. Identified as being at high risk of developing hypertension through the Hypertension Risk Assessment WeChat mini-program, with a predicted hypertension risk greater than 20%.
No current diagnosis of hypertension, with systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg, and not currently taking antihypertensive medication.
Willing to participate in the study and able to provide written informed consent.
Owns a smartphone and is able to use basic WeChat functions.
Exclusion Criteria:
Previously diagnosed hypertension or current use of antihypertensive medications.
History of serious cardiovascular or cerebrovascular disease, such as myocardial infarction or stroke.
Severe hepatic or renal dysfunction, malignant tumor, serious psychiatric disorder, or other serious disease.
Planning to move out of Shunyi District within the next 9 months. Currently participating in another similar intervention study.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Precision Intervention Group
Participants residing in community clusters assigned to the intervention group receive a hypertension risk model-based precision intervention delivered through a WeChat mini-program and community physicians.
Following baseline risk assessment, participants receive an initial face-to-face or online visit within 5 to 15 days.
Follow-up is conducted at months 1, 3, and 6, with each follow-up session lasting at least 15 minutes.
The intervention includes individualized health education, behavioral goal setting and tracking, health management tools, blood pressure monitoring guidance, and referral to a hypertension specialist when clinically indicated.
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A multicomponent precision health management intervention based on individual hypertension risk assessment.
The intervention combines a WeChat-based hypertension risk assessment and management program with community physician follow-up.
Participants receive personalized health education based on individual risk factors; behavioral goal setting and tracking for modifiable risk factors such as weight control, salt intake, and physical activity; health management tools such as salt-restriction spoons and oil-control containers; guidance on regular blood pressure monitoring; and referral to a hypertension specialist when clinically indicated.
Follow-up is conducted at 1, 3, and 6 months.
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有源比较器：Standard Health Education Group
Participants residing in community clusters assigned to the control group receive standard health education materials, general non-personalized health information, routine health education provided by community health service centers once every three months, and usual community healthcare services.
Participants may seek routine medical consultation according to standard community healthcare procedures.
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Participants receive standard non-personalized hypertension prevention and healthy lifestyle education through written educational materials, general health information, and routine health education sessions conducted once every three months at community health service centers.
Participants continue to receive usual community healthcare services and may seek routine medical consultation according to standard community healthcare procedures.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Diastolic Blood Pressure From Baseline
大体时间：Baseline to 6 months
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Change in mean diastolic blood pressure, measured in mmHg, from baseline to the prespecified follow-up time point.
Blood pressure is measured using an upper-arm electronic blood pressure monitor after the participant has rested in a seated position for at least 5 minutes.
Two measurements are obtained 1 to 2 minutes apart, and the mean of the two measurements is used.
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Baseline to 6 months
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Change in Systolic Blood Pressure From Baseline
大体时间：Baseline to 6 months
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Change in mean systolic blood pressure, measured in mmHg, from baseline to the prespecified follow-up time point.
Blood pressure is measured using an upper-arm electronic blood pressure monitor after the participant has rested in a seated position for at least 5 minutes.
Two measurements are obtained 1 to 2 minutes apart, and the mean of the two measurements is used.
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Baseline to 6 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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