Heat Emergency Awareness and Treatment (HEAT)

Heat Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03513315
• Other study ID #: IRB00089663
• Status: Completed
• Phase: N/A
• Start date: November 30, 2016
• Est. completion date: October 30, 2018

Study information

• Verified date: January 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16973
• Est. completion date: October 30, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Heat
• Heat Collapse
• Heat Exhaustion
• Heat Exposure
• Heat Illness
• Heat Stroke
• Heat Stroke and Sunstroke
• Heat Syncope, Sequela
• Stroke
• Syncope

Intervention

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

Locations

Country	Name	City	State
Pakistan	Aga Khan University	Karachi
Pakistan	The Aman Foundation	Karachi

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	Aga Khan University, Aman Foundation

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emergency Department visits	Total number of individuals requiring visit to an emergency department during the study period	3 months
Secondary	Total number of deaths (due to any cause)	Total number of deaths in the community during the study period	3 months
Secondary	Hospital admissions	Total number of hospital admissions due to any cause during the study period.	3 months