Heat IllnessHEATNCT03513315
Heat Emergency Awareness and Treatment (HEAT)
A study testing Implementation of Community-based Home Heat Bundle and Regular Community Healthcare provision in people with Heat Illness and Heat Stroke, run by Johns Hopkins University at 2 sites in Pakistan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heat Illness, Heat Stroke, Heat Exhaustion
- What is being tested?
- Implementation of Community-based Home Heat Bundle and Regular Community Healthcare provision
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16,973 participants
- Where
- 2 sitesPakistan
- Study dates
- 30 Nov 2016to 30 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- When a family refused to participate in the study
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Aga Khan University
Karachi, 74800
The Aman Foundation
Karachi
About this study
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
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.
Read the 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.
- Conditions
- Heat Illness, Heat Stroke, Heat Exhaustion, Heat Exposure, Heat Syncope, Sequela, Heat Collapse
- Being tested
- Implementation of Community-based Home Heat Bundle, Regular Community Healthcare provision
- Keywords
- Heat-related illnesses, Heat Illnesses, Community based interventions, heatwave, Pakistan, emergency preparedness, emergency medicine, heat stroke, heat exhaustion, urban health
- Medical subject headings
- Heat Stress Disorders, Heat Stroke, Heat Exhaustion, Sunstroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of Community-based Home Heat BundleBehavioural
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 provisionBehavioural
The community will get regular community health workers visit without the focus community mobilization and education on heat-related illnesses.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Community Clusters | Experimental | 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. Receives: Behavioral: Implementation of Community-based Home Heat Bundle |
| Control Community Clusters | Experimental | 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. Receives: Behavioral: Regular Community Healthcare provision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency Department visits
Total number of individuals requiring visit to an emergency department during the study period
Measured: 3 months
Secondary outcomes (2)
Total number of deaths (due to any cause)
Total number of deaths in the community during the study period
Measured: 3 months
Hospital admissions
Total number of hospital admissions due to any cause during the study period.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start30 Nov 2016
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heat IllnessStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16,973 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Aga Khan University, Aman Foundation
- Responsible party
- Sponsor
- Investigators
- Junaid A Razzak, MD PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513315
- Sponsor's protocol ID
- IRB00089663
- Acronym
- HEAT
- Status last verified
- Jan 2019
- First submitted
- 12 Apr 2018
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35101860
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03513315
- Acronym / sponsor ID
- HEAT / IRB00089663
- Conditions
- Heat Illness, Heat Stroke, Heat Exhaustion, Heat Exposure, Heat Syncope, Sequela, Heat Collapse
- Keywords
- Heat-related illnesses, Heat Illnesses, Community based interventions, heatwave, Pakistan, emergency preparedness, emergency medicine, heat stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16,973 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Aga Khan University, Aman Foundation
- Study start
- 30 Nov 2016 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 1 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Community Clusters | Experimental | Behavioral: Implementation of Community-based Home Heat BundleFor 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. |
| Control Community Clusters | Experimental | Behavioral: Regular Community Healthcare provisionEight 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- When a family refused to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation of Community-based Home Heat BundleThis 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. | Behavioural | Intervention Community Clusters |
| Regular Community Healthcare provisionThe community will get regular community health workers visit without the focus community mobilization and education on heat-related illnesses. | Behavioural | Control Community Clusters |
Primary outcome
Emergency Department visits
Time frame: 3 months
Total number of individuals requiring visit to an emergency department during the study period
2 secondary outcomes
Total number of deaths (due to any cause)
Time frame: 3 months
Hospital admissions
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Derived from this study: PubMed 35101860Razzak 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junaid A Razzak, MD PhD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of Community-based Home Heat Bundle and Regular Community Healthcare provision in people with Heat Illness and Heat Stroke, run by Johns Hopkins University at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergency Department visits (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03513315, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.