Structural Heat Adaptation and Education in Rural Setting (SHAPES Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 7,128
- 试验地点
- 1
- 主要终点
- Number of Participants with Heat-Related Illness
研究概览
简要总结
This study aims to understand whether simple, low-cost interventions, such as improved home cooling, practical advice, and minor home modifications, can help protect people's health and quality of life during periods of extreme heat in rural, low-income villages of Matiari, Pakistan.
Key Questions the Study Seeks to Answer:
- Can these interventions reduce heat-related health problems such as dizziness, headaches, and heatstroke and improve quality of life?
- Can they lower indoor temperatures and improve sleep quality, comfort, and daily functioning?
To answer these questions, researchers will compare communities where families receive heat-related support and information with similar communities that do not, to assess any differences in health and well-being. Endline venous blood sampling will be conducted for biobanking only.
What Participants Can Expect:
- Answer questions about their health, living conditions, and how they cope with heat
- Have small temperature sensors placed inside their homes
- Some participants may wear a lightweight wristband that tracks sleep and heart rate
- In selected households, cooling improvements will be made, such as adding shade, applying reflective roof paint, or enhancing airflow
Purpose:
This study seeks to identify affordable and effective strategies to help families stay safe during extreme heat, and to use these insights to support other vulnerable communities facing similar challenges.
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
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All households within the selected clusters who provide consent.
排除标准
- •Households planning to move away from the study site within the next 6 months
- •Individuals with severe mental or physical health conditions that preclude participation
研究组 & 干预措施
Heat Adaptation Bundle
The Resilience and Heat Adaptation Bundle (ReHAB) consists of two components; community education and awareness and participatory local structural and environmental heat mitigation solutions. The behavioral and educational interventions will be delivered through community mobilization whereas structural interventions will encompass modifications in the existing structures to lower the indoor ambient temperature and reduce heat effects.
干预措施: Participatory local structural and environmental heat mitigation solutions (Other)
Control
The control arm will not receive any intervention.
结局指标
主要结局
Number of Participants with Heat-Related Illness
时间窗: from baseline to 24 months
Heat-related illness is defined as any condition resulting from prolonged heat exposure, including heat stroke, heat exhaustion, heat syncope, heat cramps, or heat rash. Data will be collected through weekly household surveillance, and community group reports.
Quality of Life Enhancement
时间窗: 4 month, 7 month, 16 month, 19 month
Change in the WHO Quality of Life Brief Tool (WHOQOL-BREF) overall score (mean of domain scores) during two consecutive peak summer and winter seasons. The WHOQOL-BREF questionnaire assess the quality of life across four domains, uses a 5-point Likert scale for its 26 items, with higher scores indicating a better quality of life. The scores are generally transformed into a 0-100 scale for reporting
次要结局
- All-cause mortality (Number of Deaths from Any Cause)(from baseline to 24 months)
- Number of Participants with At Least One Hospital Visit During Study Period(During summer months for 2 years)
- Number of Participants Hospitalized for at Least 24 Hours(During summer months for 2 years)
- Change in Self-Reported Thermal Comfort Score(from baseline to 24 months)
- Change in Indoor Heat Index(From intervention delivery to 24 months)
研究者
Dr Jai Kumar Das
Associate Professor, Associate Director, Institute for Global Health and Development
Aga Khan University