An interventional study of Implementation of Community-based Home Heat Bundle and Regular Community Healthcare provision in Heat Illness, Heat Stroke and Heat Exhaustion, sponsored by Johns Hopkins University. Completed at 2 sites in Pakistan. Per ClinicalTrials.gov, last updated 2019-01-09.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Prevention
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.
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.
21 studies on the registry are indexed under Heat Stroke; 10 are open to participants now.
This study's enrollment of 16,973 is above the median of 34 across 13 interventional studies indexed under Heat Stroke.
Browse Heat Stroke studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Compared within Heat Stroke, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Heat Stress Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
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
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
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.
The community will get regular community health workers visit without the focus community mobilization and education on heat-related illnesses.
Emergency Department visits
Total number of individuals requiring visit to an emergency department during the study period
Time frame: 3 months
Total number of deaths (due to any cause)
Total number of deaths in the community during the study period
Time frame: 3 months
Hospital admissions
Total number of hospital admissions due to any cause during the study period.
Time frame: 3 months
Plan to share: No
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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