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Heat Emergency Awareness and Treatment (HEAT) (HEAT)

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ClinicalTrials.gov Identifier: NCT03513315
Recruitment Status : Completed
First Posted : May 1, 2018
Last Update Posted : January 9, 2019
Sponsor:
Collaborators:
Aga Khan University
Aman Foundation
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
Investigators propose an intervention trial of a comprehensive education and treatment bundle designed to reduce morbidity and mortality associated with heat-related illness for low resource settings. Two set of interventions will be developed each for emergency department and for community/home. These interventions will be developed by an internal expert group and will be customized and implemented at the home and emergency department (ED) levels, will include evidence-based educational training guidelines for ED health providers as well as educational messages targeting home and community in Karachi, Pakistan.

Condition or disease Intervention/treatment Phase
Heat Illness Heat Stroke Heat Exhaustion Heat Exposure Heat Syncope, Sequela Heat Collapse Heat Heat Stroke and Sunstroke Behavioral: Implementation of Community-based Home Heat Bundle Behavioral: Regular Community Healthcare provision Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16973 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : November 30, 2016
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : October 30, 2018

Arm Intervention/treatment
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.
Behavioral: Implementation of Community-based Home Heat Bundle
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.

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.
Behavioral: Regular Community Healthcare provision
The community will get regular community health workers visit without the focus community mobilization and education on heat-related illnesses.




Primary Outcome Measures :
  1. Emergency Department visits [ Time Frame: 3 months ]
    Total number of individuals requiring visit to an emergency department during the study period


Secondary Outcome Measures :
  1. Total number of deaths (due to any cause) [ Time Frame: 3 months ]
    Total number of deaths in the community during the study period

  2. Hospital admissions [ Time Frame: 3 months ]
    Total number of hospital admissions due to any cause during the study period.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03513315


Locations
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Pakistan
Aga Khan University
Karachi, Pakistan, 74800
The Aman Foundation
Karachi, Pakistan
Sponsors and Collaborators
Johns Hopkins University
Aga Khan University
Aman Foundation
Investigators
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Principal Investigator: Junaid A Razzak, MD PhD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03513315     History of Changes
Other Study ID Numbers: IRB00089663
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
Heat-related illnesses
Heat Illnesses
Community based interventions
heatwave
Pakistan
emergency preparedness
emergency medicine
heat stroke
heat exhaustion
urban health
Additional relevant MeSH terms:
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Stroke
Syncope
Emergencies
Heat Stroke
Sunstroke
Heat Exhaustion
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Heat Stress Disorders
Wounds and Injuries