Interventional Recruiting
NCT06983483 on ClinicalTrials.gov
Structural Heat Adaptation and Education in Rural Setting
Official title: Structural Heat Adaptation and Education in Rural Setting (SHAPES Trial)
- Sponsor: Aga Khan University (Pakistan)
- Collaborators: London School of Hygiene and Tropical Medicine, University College, London
- Enrollment: 7128 (Estimated)
- Study start: 2026-01-01 (Actual)
- Primary completion: 2027-12-31 (Estimated)
- Study completion: 2028-02-01 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- InterventionModelDescription: Cluster Randomized Controlled Trial
- Masking: Single (Outcomes Assessor)
- PrimaryPurpose: Prevention
Brief Summary
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:
1. Can these interventions reduce heat-related health problems such as dizziness, headaches, and heatstroke and improve quality of life?
2. 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.
Conditions
- Heat Illness
- Quality of Life
Intervention / Treatment
- Behavioral: Community education and awareness
- Other: Participatory local structural and environmental heat mitigation solutions
Primary Outcome Measures
-
Number of Participants with Heat-Related Illness
(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
(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
Countries
Pakistan
Locations and Investigators
- Aga Khan University Hospital, Matiari, Pakistan (Recruiting)
Study Officials
- jai K Das (Principal Investigator) — Institute for Global Health and Development, Aga Khan University.