Heat Emergency Awareness and Treatment (HEAT) (HEAT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03513315|
Recruitment Status : Completed
First Posted : May 1, 2018
Last Update Posted : January 9, 2019
|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|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||16973 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Emergency Department visits [ Time Frame: 3 months ]Total number of individuals requiring visit to an emergency department during the study period
- Total number of deaths (due to any cause) [ Time Frame: 3 months ]Total number of deaths in the community during the study period
- Hospital admissions [ Time Frame: 3 months ]Total number of hospital admissions due to any cause during the study period.
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
|Aga Khan University|
|Karachi, Pakistan, 74800|
|The Aman Foundation|
|Principal Investigator:||Junaid A Razzak, MD PhD||Johns Hopkins University|