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Clinical Trials/NCT06539845
NCT06539845
Recruiting
N/A

Development and Effectiveness of a New Intervention on Household Preparedness for Disease X and Outbreaks Among Orang Asli in Selangor: A Cluster Randomized Trial

Universiti Teknologi Mara1 site in 1 country96 target enrollmentJune 2025

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
Universiti Teknologi Mara
Enrollment
96
Locations
1
Primary Endpoint
Household Preparedness Score
Status
Recruiting
Last Updated
last year

Overview

Brief 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.
Registry
clinicaltrials.gov
Start Date
June 2025
End Date
September 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ameerah Su'ad binti Abdul Shakor

Principal Investigator

Universiti Teknologi Mara

Eligibility Criteria

Inclusion Criteria

  • Orang Asli ethnicity
  • Malaysian citizen
  • Age between 18 to 99 years old
  • The head of the household, or the person who contributes to, or influences health-related decisions for the household
  • Live in a household with at least three members
  • Able to converse in Malay

Exclusion Criteria

  • Having physical or cognitive disabilities (e.g., blindness, deafness, schizophrenia and dementia)
  • Having severe health conditions (e.g., respiratory and cardiovascular disease requiring oxygen support such as severe asthma/chronic obstructive pulmonary disease/heart failure and congenital heart diseases)
  • Residing temporarily (less than 2 years)
  • Intending to relocate to a different residence within the next 2 years

Outcomes

Primary Outcomes

Household Preparedness Score

Time Frame: Before intervention (T0), immediately after the intervention (T1), 1-month follow-up (T2), and at a 2-months follow-up (T3)

The combined scores of awareness/attitude and the preparedness actions of the participant in a specific area towards potential disasters. The preparedness level is measured on a 4-category scale: Fully prepared, Committed, Aware, and Least prepared or unprepared.

Household Preparedness Matrix

Time Frame: Before intervention (T0), immediately after the intervention (T1), 1-month follow-up (T2), and at a 2-months follow-up (T3)

Based on the "Household Preparedness Score", the level of preparedness by assigning each respondent a position on the matrix based on their questionnaire responses.

Secondary Outcomes

  • Cognitive Preparedness score(Before intervention (T0), immediately after the intervention (T1), 1-month follow-up (T2), and at a 2-months follow-up (T3))
  • Preparedness Behaviour score(Before intervention (T0), immediately after the intervention (T1), 1-month follow-up (T2), and at a 2-months follow-up (T3))

Study Sites (1)

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