Clinical Trial

Creating a New Health Promotion Module to Help the Indigenous People of Selangor Prepare for Disease X and Outbreaks

Recruiting
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Record status
This record was last updated April 16, 2025 (before its estimated September 2025 completion). Its status may not reflect the trial's current state.
Summary
The goal of this cluster randomized trial is to develop and test a new method for preparing indigenous (locally termed as Orang Asli) households in Selangor, a state in Malaysia, for outbreaks and Disease X, a potential unknown infectious threat. It aims to determine if the new method, a health education package comprised of workshops, simulation exercises, and card game play sessions, can enhance the readiness of these families for such outbreaks. The main questions it is looking to answer are: 1. Will the intervention package increase the level of preparedness for a Disease X and outbreaks among indigenous households in Selangor? 2. Will the intervention improve the awareness and attitudes of the indigenous people in Selangor towards outbreak preparedness? 3. Will it lead to more proactive preparedness actions by these households? To evaluate the effectiveness of the intervention package, researchers will compare outcomes between two groups: the intervention group receiving both the intervention package and educational brochures on communicable disease prevention, and the control group receiving only the brochures. Participants will: 1. Participate in the activities in the newly developed intervention package, which would include workshops, simulation exercises, and card game play sessions. 2. Answer surveys four times: before, immediately after, 1 month after and 2 months after the intervention, to measure any changes in their preparedness levels for an outbreak.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-08-01; most recent amendment 2025-04-12.
Status change: Enrolling by Invitation → Recruiting 2025-04-12
Status change: Not Yet Recruiting → Enrolling by Invitation 2025-03-25
Trial Details
NCT Number NCT06539845
Lead Sponsor Universiti Teknologi Mara
Collaborators: Ministry of Health, Malaysia, Universiti Putra Malaysia, Institute for Health Behavioural Research, Department of Orang Asli Development
Conditions Attitude to Health, Behavior, Health, Health Behavior, Health-Related Behavior, Health Attitude, Health Knowledge, Attitudes, Practice, Knowledge, Attitudes, Practice, Preparedness +1 more
Enrollment 96 participants
Start Date 2025-06
Primary Completion 2025-09 (estimated)
Study Completion 2025-09 (estimated)
Updated on ClinicalTrials.gov 2025-04-16