Engaging Religious Leaders to Reduce Blood Pressures in Tanzanian Communities
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 16,046
- 试验地点
- 3
- 主要终点
- Mean change in community systolic blood pressure
研究概览
简要总结
The investigators hypothesize that communities in which religious leaders are provided with education about blood pressure and how to measure blood pressure will have lower overall average blood pressures than communities in which religious leaders do not receive education about blood pressure.
详细描述
This research is being done to determine whether the Religious Engagement in Health Intervention can reduce community blood pressure. The study is being conducted in the Northwestern Tanzania. 20 communities will be involved: 10 will be randomized to the Religious Engagement in Health Intervention arm, and 10 will be randomized to the control arm. The Religious Engagement in Health Intervention includes the following three evidence-based components: (1) educational sessions for Christian and Muslim leaders on religious teachings and medical aspects of blood pressure, (2) equipping religious leaders to provide blood pressure teaching in their communities using knowledge learned from educational sessions and through longitudinal mentorship meetings, and (3) community blood pressure screening organized by religious leaders in partnership with local health care workers, and referrals for clinical care as needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult ≥35 years of age
- •Has lived in the community for ≥1 year
- •Household identified for random sampling is primary residence: has slept in the household at least once in the past 2 weeks and considers this their primary residence
排除标准
- •First-degree relative from the same household already enrolled
- •Relative of the same sex from the same household already enrolled
研究组 & 干预措施
Control communities
Communities randomized to the control arm will receive a strengthening of the capacity to manage blood pressure at their local health center. Healthcare workers at the local health center will receive standard supplies, reference materials, and training in blood pressure measurement and management on-site. In the event of any stock-outs due to higher demand for antihypertensives during the trial implementation, the trial will temporarily provide these medications to primary health facilities until the Ministry of Health supply chain is restored. Of note, control communities will receive Religious Engagement in Health Intervention after the trial is complete.
Religious Engagement in Health Intervention communities
Communities randomized to the intervention arm will receive a strengthening of the capacity to manage blood pressure at their local health center plus Religious Engagement in Health Intervention for blood pressure (BP), which includes three evidence-based components; 1) educational sessions for Christian and Muslim leaders on religious teachings and medical aspects of BP, 2) equipping religious leaders to provide BP teaching in their communities using knowledge learned from educational sessions and through longitudinal mentorship meetings, and 3) community BP screening organized by religious leaders in partnership with local health care workers, and referrals for clinical care as needed.
干预措施: Religious Engagement in Health Intervention (Behavioral)
结局指标
主要结局
Mean change in community systolic blood pressure
时间窗: Baseline; 12months
Before and 12 months after the intervention, investigators will estimate the true mean community BP by sampling 400 randomly selected adult community members (age ≥35 years) in each of the 20 communities.
Mean Change in Community Systolic Blood Pressure
时间窗: Baseline; 12months
Before and 12 months after the intervention, investigators will estimate the true mean community BP by sampling 400 randomly selected adult community members (age ≥35 years) in each of the 20 communities.
次要结局
- Change in minutes of physical exercise per week(Baseline; 24 months)
- Reach of the intervention(24 months)
- Effectiveness of the intervention(24 months)
- Mean change in community systolic blood pressure(Baseline; 24 months)
- Change in awareness of hypertension(Baseline; 24 months)
- Change in Body Mass Index(Baseline; 24 months)
- Change in fruit intake(Baseline; 24 months)
- Adoption of the intervention(24 months)
- Change in treatment of hypertension(Baseline; 24 months)
- Change in waist circumference(Baseline; 24 months)
- Change in vegetables intake(Baseline; 24 months)
- Maintenance of the intervention(24 months)
- Change in Awareness of Hypertension(Baseline; 12 months)
- Change in Awareness of Hypertension(Baseline; 24 months)
- Change in Treatment of Hypertension(Baseline; 12 months)
- Change in Treatment of Hypertension(Baseline; 24 months)
- Change in Waist Circumference(Baseline; 12 months)
- Change in Waist Circumference(Baseline; 24 months)
- Change in Fruit Intake(Baseline; 12 months)
- Change in Fruit Intake(Baseline; 24 months)
- Change in Vegetables Intake(Baseline; 12 months)
- Change in Vegetables Intake(Baseline; 24 months)
- Change in Minutes of Physical Exercise Per Week(Baseline; 12 months)
- Change in Minutes of Physical Exercise Per Week(Baseline; 24 months)
- Reach of the Intervention(24 months)
- Effectiveness of the Intervention(24 months)
- Adoption of the Intervention(24 months)
- Maintenance of the Intervention(24 months)
- Mean Change in Community Systolic Blood Pressure(Baseline; 24 months)