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Heat Emergency Awareness and Treatment (HEAT) (HEAT)

Primary Purpose

Heat Illness, Heat Stroke, Heat Exhaustion

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Implementation of Community-based Home Heat Bundle
Regular Community Healthcare provision
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heat Illness focused on measuring Heat-related illnesses, Heat Illnesses, Community based interventions, heatwave, Pakistan, emergency preparedness, emergency medicine, heat stroke, heat exhaustion, urban health

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aga Khan University
  • The Aman Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention Community Clusters

Control Community Clusters

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Emergency Department visits
Total number of individuals requiring visit to an emergency department during the study period

Secondary Outcome Measures

Total number of deaths (due to any cause)
Total number of deaths in the community during the study period
Hospital admissions
Total number of hospital admissions due to any cause during the study period.

Full Information

First Posted
April 12, 2018
Last Updated
January 7, 2019
Sponsor
Johns Hopkins University
Collaborators
Aga Khan University, Aman Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03513315
Brief Title
Heat Emergency Awareness and Treatment (HEAT)
Acronym
HEAT
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 30, 2016 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Aga Khan University, Aman Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heat Illness, Heat Stroke, Heat Exhaustion, Heat Exposure, Heat Syncope, Sequela, Heat Collapse, Heat, Heat Stroke and Sunstroke
Keywords
Heat-related illnesses, Heat Illnesses, Community based interventions, heatwave, Pakistan, emergency preparedness, emergency medicine, heat stroke, heat exhaustion, urban health

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16973 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Community Clusters
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Community Clusters
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Implementation of Community-based Home Heat Bundle
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Regular Community Healthcare provision
Intervention Description
The community will get regular community health workers visit without the focus community mobilization and education on heat-related illnesses.
Primary Outcome Measure Information:
Title
Emergency Department visits
Description
Total number of individuals requiring visit to an emergency department during the study period
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Total number of deaths (due to any cause)
Description
Total number of deaths in the community during the study period
Time Frame
3 months
Title
Hospital admissions
Description
Total number of hospital admissions due to any cause during the study period.
Time Frame
3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junaid A Razzak, MD PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga Khan University
City
Karachi
ZIP/Postal Code
74800
Country
Pakistan
Facility Name
The Aman Foundation
City
Karachi
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35101860
Citation
Razzak JA, Agrawal P, Chand Z, Quraishy S, Ghaffar A, Hyder AA. Impact of community education on heat-related health outcomes and heat literacy among low-income communities in Karachi, Pakistan: a randomised controlled trial. BMJ Glob Health. 2022 Jan;7(1):e006845. doi: 10.1136/bmjgh-2021-006845.
Results Reference
derived

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Heat Emergency Awareness and Treatment (HEAT)

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