Creating a New Plan to Help the Indigenous People of Selangor Prepare for a Disease X Outbreak
NCT Number: NCT06539845
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Attitude to Health|Behavior, Health|Health Behavior|Health-Related Behavior|Health Attitude|Health Knowledge, Attitudes, Practice|Knowledge, Attitudes, Practice
Interventions: BEHAVIORAL: Outbreak Preparedness Intervention for the Orang Asli|BEHAVIORAL: Educational Brochures for the Orang Asli
Sponsor: Universiti Teknologi Mara
Collaborators: Ministry of Health, Malaysia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-12
Completion Date: 2025-06

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 an outbreak of 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 outbreak 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.

Primary Outcome Measures: Household Preparedness Score, 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., Before intervention (T0), immediately after the intervention (T1), 1-month follow-up (T2), and at a 2-months follow-up (T3)|Household Preparedness Matrix, Based on the "Household Preparedness Score", the level of preparedness by assigning each respondent a position on the matrix based on their questionnaire responses., Before intervention (T0), immediately after the intervention (T1), 1-month follow-up (T2), and at a 2-months follow-up (T3)
Secondary Outcome Measures: Awareness and Attitude score, Measures the knowledge or understanding of participant regarding disaster awareness Additionally, gathering insights about people's perception of possible risk hazard that may affect them including the consequences and how to mitigate. The score is derived from the total sum of marks gathered from each item within the Awareness and Attitude domain and normalized into a scale of 0 to 1., Before intervention (T0), immediately after the intervention (T1), 1-month follow-up (T2), and at a 2-months follow-up (T3)|Preparedness Actions score, Measures the current level of preparedness action that has been done by participants. The score is derived from the total sum of marks gathered from each item within the Preparedness Actions domain and normalized into a scale of 0 to 1., Before intervention (T0), immediately after the intervention (T1), 1-month follow-up (T2), and at a 2-months follow-up (T3)