Aga Khan University Hospital
Matiari, Pakistan
Location status: Recruiting
NCT Number: NCT06983483
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.
Interested in participating?
Request InfoAll sexes
Interventional
Not applicable
Matiari, Pakistan
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This component of the ReHAB will be achieved through community mobilization, which will encompass awareness and motivational activities throughout the intervention duration. Community groups (CGs) will be formed in each of the 11 clusters. Both male and female CGs will be formed separately and will be responsible for community mobilization activities, surveillance for primary outcome. Each CG will comprise of 6-8 members and will be a diverse group of people with varying qualifications, including local government members, local elders/elites, religious leaders, and prominent male and female members of the community. they could also name their respective CGs to enhance association, identity, and affiliation. These CGs will facilitate culturally tailored workshops, dissemination of early warnings regarding heat waves, awareness sessions, and door-to-door outreach focused on heat-health fundamentals. CGs will also maintain simple logbooks to track any incidence of heat related illness.
Other names: behavioral change, early warning system
Participatory local structural and environmental heat mitigation solutions will be delivered through community participatory approach where the community and project will share the cost of intervention to improve ownership. This contribution can be monetary or non-monetary, for example, provision of labor or supplies. The modifications include:
Time frame: 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.
Time frame: 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
Time frame: from baseline to 24 months
All-cause mortality refers to the total number of deaths from any cause among trial participants during the study period, confirmed via household visits and healthcare facility records.
Time frame: During summer months for 2 years
Defined as the number of participants who visited a secondary or tertiary healthcare facility for any reason during the study period, confirmed by self-report and facility-based records.
Time frame: During summer months for 2 years
Defined as the number of participants who were admitted to a hospital for at least 24 consecutive hours during the study period, verified through hospital admission records and participant reports.
Time frame: from baseline to 24 months
Thermal comfort will be assessed using a modified version of the CHEQ-5 thermal comfort survey. Participants rate their satisfaction with indoor thermal conditions. The scale ranges from 1 (very uncomfortable) to 5 (very comfortable). Higher scores indicate better thermal comfort. Assessments will be conducted at baseline, and then monthly.
Time frame: From intervention delivery to 24 months
Measured as the difference in average indoor heat index before and after intervention using fixed indoor temperature loggers (iButton sensors or Temp-U data loggers). Data collected continuously throughout the study.
Time frame: From baseline to 24 months
Defined as a biometeorological index that describes the human body's physiological response to the environment. It integrates air temperature, humidity, wind speed, and radiant temperature to assess the overall thermal stress on the human body
Time frame: During summer months for 2 years
Defined as the average temperature experienced by an individual, measured continuously using wearable temperature monitors. Data will be collected across both indoor and outdoor settings for each participant.
Time frame: During summer months for 2 years
Heart rate will be measured using Fitbit Inspire 3 devices. Data are recorded at hourly intervals. The outcome will be reported as the change in average heart rate from baseline to follow-up.
Time frame: During summer months for 2 years
Sleep quality will be assessed using Fitbit Inspire 3, which detects sleep stages (REM, light, deep) and wakefulness. Data include total sleep time, sleep efficiency, and time spent in each stage. Higher efficiency and longer sleep duration indicate better sleep quality.
Time frame: During summer months for 2 years
Measured using Fitbit Inspire 3 devices. Participants will be categorized as sedentary, lightly active, moderately active, or very active based on daily movement data (step counts, active minutes). Categories follow Fitbit's proprietary activity classification algorithm.
Time frame: During summer months for 2 years
Measured using Fitbit Inspire 3. This includes calories burned through basal metabolic rate and physical activity. Reported as the average number of kilocalories burned per day per participant.
Time frame: Endline
Measured as the difference in cost divided by the difference in health effect between the intervention and control groups
Contact information is provided by the study sponsor or research team.
Aga Khan University
Other
Structural Heat Adaptation and Education in Rural Setting (SHAPES Trial)
Acronym: SHAPES
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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