- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03513315
Heat Emergency Awareness and Treatment (HEAT) (HEAT)
Heat Emergency Awareness and Treatment (HEAT): A Cluster Randomized Trial to Assess the Impact of a Comprehensive Intervention to Mitigate Humanitarian Crisis Due to Extreme Heat in Karachi, Pakistan
Study Overview
Status
Conditions
Detailed Description
This study consists of a community-based and hospital-based components. The community-based study is a prospective two-arm cluster randomized controlled trial and will be implemented in 16 clusters of 1000 people located in the most central neighborhood (called "mohalla") of a Union Council. Minimum required sample size is 7120 in each group, which requires 890 subjects in each of the 16 clusters. Calculations are based on achieving 80% power to detect a difference between the group proportions of 20% from the baseline.
For the hospital component, four major hospitals will be randomized to receive operations and clinical capacity building on management of heat emergencies. The hospital sample size is limited by the availability of hospitals and their uneven distribution which are not linked to union councils in the district.
The primary outcome in the investigators' study is the frequency of emergency admissions to the hospital with all-cause mortality as a secondary outcome.
A community-based and hospital-based protocols and training materials will be developed and will serve as the intervention in this study. These will focus on education about recognizing the signs of symptoms of heat-related illness and proper response and treatment based on local resources.
Data collection will be done at baselines and post-intervention. In the community data on demographics and household characteristics will be collected. Additionally, data on deaths in households will be collected. Changes in knowledge, attitudes, and practices will be measured using a Knowledge, Attitudes, and Practices (KAP) survey pre- and post-intervention.
In the hospital, data collection will focus on emergency department admissions, visits, mortality, and heat index. Changes in physician knowledge will be measures with a KAP survey pre- and post-intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Karachi, Pakistan, 74800
- Aga Khan University
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Karachi, Pakistan
- The Aman Foundation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients presenting to the emergency departments in Karachi who present with suspected heat stroke/heat exhaustion and basic information about their presentation and treatment will be obtained in the ED for May-July.
- Community households in "Korangi District"
- Physicians/Nurses working in the emergency department of study hospital sites
Exclusion Criteria:
- When a family refused to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Intervention Community Clusters
For the community-based arm of the study, 16 clusters will be randomized into intervention and control groups.
Those in the intervention group will receive implementation of community-based Home Heat Bundle.
This Bundle includes education from community health workers on the signs and symptoms of heat-related illness, how to prevent the illness, and when to seek treatment.
In addition, the intervention group will receive SMS messaging with information about heatwaves.
The education and Short Message Service (SMS) messaging will occur in March and April via meetings in households and in public spaces.
There will be a total of 40 activities, each lasting approximately two hours.
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This community-based intervention include a set of educational materials to increase awareness about heat-related illness and prevention with the intention of reducing the incidence of heat-related and reducing mortality associated with heat-related illness.
Materials used in this intervention will include posters, brochures, in-person training, and SMS messaging.
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Experimental: Control Community Clusters
Eight community clusters of 1000 population each where regular community-based healthcare services will be provided without focused interventions on identification and management of heat-related illnesses.
These clusters will receive regular community healthcare provision.
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The community will get regular community health workers visit without the focus community mobilization and education on heat-related illnesses.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Emergency Department visits
Time Frame: 3 months
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Total number of individuals requiring visit to an emergency department during the study period
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total number of deaths (due to any cause)
Time Frame: 3 months
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Total number of deaths in the community during the study period
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3 months
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Hospital admissions
Time Frame: 3 months
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Total number of hospital admissions due to any cause during the study period.
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3 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Junaid A Razzak, MD PhD, Johns Hopkins University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Wounds and Injuries
- Neurobehavioral Manifestations
- Disease Attributes
- Unconsciousness
- Consciousness Disorders
- Stroke
- Emergencies
- Syncope
- Heat Stress Disorders
- Heat Stroke
- Sunstroke
- Heat Exhaustion
Other Study ID Numbers
- IRB00089663
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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