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临床试验/NCT03513315
NCT03513315已完成不适用

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

Johns Hopkins University3 个研究点 分布在 1 个国家目标入组 16,973 人开始时间: 2016年11月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16,973
试验地点
3
主要终点
Emergency Department visits

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • When a family refused to participate in the study

研究组 & 干预措施

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.

干预措施: Implementation of Community-based Home Heat Bundle (Behavioral)

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.

干预措施: Regular Community Healthcare provision (Behavioral)

结局指标

主要结局

Emergency Department visits

时间窗: 3 months

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

次要结局

  • Total number of deaths (due to any cause)(3 months)
  • Hospital admissions(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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Heat Emergency Awareness and Treatment (HEAT) | 临床试验