NCT03513315

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16,973

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

1.9 years

First QC Date

April 12, 2018

Last Update Submit

January 7, 2019

Conditions

Keywords

Heat-related illnessesHeat IllnessesCommunity based interventionsheatwavePakistanemergency preparednessemergency medicineheat strokeheat exhaustionurban health

Outcome Measures

Primary Outcomes (1)

  • Emergency Department visits

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

    3 months

Secondary Outcomes (2)

  • Total number of deaths (due to any cause)

    3 months

  • Hospital admissions

    3 months

Study Arms (2)

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.

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.

Behavioral: Regular Community Healthcare provision

Interventions

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 Community Clusters

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

Control Community Clusters

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • When a family refused to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aga Khan University

Karachi, 74800, Pakistan

Location

The Aman Foundation

Karachi, Pakistan

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Heat Stress DisordersHeat StrokeHeat ExhaustionSunstroke

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Junaid A Razzak, MD PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2018

First Posted

May 1, 2018

Study Start

November 30, 2016

Primary Completion

October 30, 2018

Study Completion

October 30, 2018

Last Updated

January 9, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations