Cluster Randomized Controlled Trial for a Community Health Promotion Program: Community Health Assessment Program in the Philippines (CHAP-P)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,229
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
This study aims to evaluate the effectiveness of the Community Health Assessment Program in the Philippines (CHAP-P), looking at the differences between communities implementing CHAP-P versus communities not implementing CHAP-P.
详细描述
In this study, the investigators are evaluating the effectiveness of the CHAP-P intervention in communities of the Zamboanga Peninsula, Philippines. Specifically, the investigators are looking at the difference between hemoglobin A1c (HbA1c) levels in randomly selected residents of control communities versus those in communities implementing the CHAP-P intervention. The investigators are also looking at the differences between control and intervention communities in modifiable lifestyle risk factors for diabetes, screening rates for diabetes, rates of newly diagnosed cases of diabetes, general diabetes management, and hospital admission rates, as well as the cost effectiveness of CHAP-P.
The CHAP-P intervention consists of initial and follow-up sessions where trained local volunteers (Barangay Health Workers, or BHWs) take physical measurements (blood pressure, height, weight, waist circumference) and facilitate a diabetes risk survey; based on these findings, they provide education, materials, and referrals to local health resources as needed.
The participant groups in this evaluation include those that attend CHAP-P sessions, randomly selected community members that provide consent for a survey and HbA1c testing, and community members and BHWs/other Lead Local Organization staff who provide consent for focus groups and interviews.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
HbA1c
时间窗: Baseline, 6 months
Mean difference in HbA1c at 6 months in the intervention group compared to the control group. Measured with the A1CNow+ point-of-care device in a community location after the completion of the in-home community survey.
次要结局
- Physical Activity(Baseline, 6 months)
- Medication Compliance(Baseline, 6 months)
- Hospital admission rates(-12 months, 12 months)
- Confidence in Behaviour Change(Baseline, 6 months)
- Blood Pressure(Baseline, 6 months)
- Community Residents Newly Diagnosed with Diabetes(6 months)
- Knowledge about Diabetes and Hypertension(Baseline, 6 Months)
- Risk Behaviours for Diabetes/Cardiovascular Issues(Baseline, 6 months)
- Quality-Adjusted Life Years (QALYs)(12 months)
- Quality of Life (EQ5D-5L)(Baseline, 6 months)
- Cost-effectiveness(12 months)
- Cost-utility(12 months)
- Mortality rates(-12 months, 12 months)
- Risk Factors for Diabetes(Baseline, 6 months)
- Perceived Concern and Understanding of Risk(Baseline, 6 months)