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| ID | Type | Description | Link |
|---|---|---|---|
| 226752/Z/22/Z | Other Grant/Funding Number | Wellcome Trust |
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| Name | Class |
|---|---|
| London School of Hygiene and Tropical Medicine | OTHER |
| University College, London | OTHER |
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heat Adaptation Bundle | Experimental | 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. |
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| Control | No Intervention | The control arm will not receive any intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community education and awareness | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Heat-Related Illness | 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. | from baseline to 24 months |
| Quality of Life Enhancement | 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 | 4 month, 7 month, 16 month, 19 month |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality (Number of Deaths from Any Cause) | 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. | from baseline to 24 months |
| Number of Participants with At Least One Hospital Visit During Study Period |
| Measure | Description | Time Frame |
|---|---|---|
| Personalized Heat Exposure (°C) | 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. | During summer months for 2 years |
| Change in Heart Rate (Beats per Minute) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jai K Das | Contact | +922134864717 | 64717 | jai.das@aku.edu |
| Name | Affiliation | Role |
|---|---|---|
| jai K Das | Institute for Global Health and Development, Aga Khan University. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aga Khan University Hospital | Recruiting | Matiari | Pakistan |
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Upon reasonable request.
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| ID | Term |
|---|---|
| D018882 | Heat Stress Disorders |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Cluster Randomized Controlled Trial
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| Participatory local structural and environmental heat mitigation solutions | Other | 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:
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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. |
| During summer months for 2 years |
| Number of Participants Hospitalized for at Least 24 Hours | 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. | During summer months for 2 years |
| Change in Self-Reported Thermal Comfort Score | 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. | from baseline to 24 months |
| Change in Indoor Heat Index | 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. | From intervention delivery to 24 months |
| Universal Thermal Climate Index (UTCI) | 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 | From baseline to 24 months |
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. |
| During summer months for 2 years |
| Sleep quality | 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. | During summer months for 2 years |
| Physical Activity Level Based on Daily Step Count and Activity Classification | 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. | During summer months for 2 years |
| Total Daily Energy Expenditure (Kilocalories) | 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. | During summer months for 2 years |
| Cost-effectiveness | Measured as the difference in cost divided by the difference in health effect between the intervention and control groups | Endline |