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

StatusRecruiting
PhaseNot applicable
Started
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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.

Record History

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  1. Notable Start date: Feb 15, 2025 to Jun 2025
    • Trial status: Enrolling by Invitation to Recruiting
    • Study sites: 1 to 2
    • Primary and study completion dates: Jun 2025 to Sep 2025
    v5
  2. Notable Trial status: Not Yet Recruiting to Enrolling by Invitationv4 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary and study completion dates: May 24, 2025 to Jun 2025
    • Start date changed from estimate of Feb 1, 2025 to Feb 15, 2025
    • Eligibility criteria shortened, about 5 words
  3. Notable Start date: Dec 2024 to Feb 1, 2025v3 Show 6 more changesShow less
    • Enrollment target: 90 to 96
    • Primary and study completion dates: Jun 2025 to May 24, 2025
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints revised (2)
    • Collaborators: 1 to 4
    • Study title expanded, about 2 words
  4. Minor Eligibility criteria shortened, about 10 wordsv2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)
Attitude to Health, Behavior, Health, Health Behavior, Health-Related Behavior, Health Attitude, Health Knowledge, Attitudes, Practice, Knowledge, Attitudes, Practice, Preparedness +1 more
Related terms Behavior, Health Behavior
Enrollment 96 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov