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

NCT06539845 | Recruiting

• 1 other identifier: 24-01859-NQ7
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

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. 1.Will the intervention package increase the level of preparedness for a Disease X and outbreaks among indigenous households in Selangor?
2. 2.Will the intervention improve the awareness and attitudes of the indigenous people in Selangor towards outbreak preparedness?
3. 3.Will it lead to more proactive preparedness actions by these households?
4. 4.Participate in the activities in the newly developed intervention package, which would include workshops, simulation exercises, and card game play sessions.
5. 5.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.

Conditions

Attitude to Health; Behavior, Health; Health Behavior; Health-Related Behavior; Health Attitude; Health Knowledge, Attitudes, Practice; Knowledge, Attitudes, Practice; Preparedness; Outbreaks

Keywords

Indigenous People; Aboriginal; Preparedness; Readiness; Community Trial; Outbreak

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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 Arms (2)

Intervention

EXPERIMENTAL

Randomly selected Orang Asli villages will receive the intervention package along with educational brochures, through a workshop they will need to participate in once.

Behavioral: Outbreak Preparedness Intervention for the Orang Asli

Control

ACTIVE COMPARATOR

Randomly selected Orang Asli villages that will receive the educational brochures only.

Behavioral: Educational Brochures for the Orang Asli

Interventions

Outbreak Preparedness Intervention for the Orang Asli BEHAVIORAL

The chosen villages will be given the intervention package, which includes a workshop, simulation exercises, and a card game, in addition to educational brochures on communicable disease prevention sourced from the Ministry of Health Malaysia "Info Sihat" website. This entire package will be delivered once, during the workshop, after they have answered the survey at T0.

Intervention

Educational Brochures for the Orang Asli BEHAVIORAL

The chosen villages will be given educational brochures on communicable disease prevention sourced from the Ministry of Health Malaysia "Info Sihat" website. This will be given once during the first encounter with the participant, after they have answered the survey at T0.

Control

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Teknologi Mara: lead
• Ministry of Health, Malaysia: collaborator
• Universiti Putra Malaysia: collaborator
• Institute for Health Behavioural Research: collaborator
• Department of Orang Asli Development: collaborator

Study Sites (2)

Pejabat JAKOA Daerah Gombak dan Petaling

Gombak, Selangor, 53100, Malaysia

ENROLLING BY INVITATION

Pejabat JAKOA Daerah Gombak dan Petaling

Gombak, Selangor, 53100, Malaysia

RECRUITING

MeSH Terms

Conditions

Health Behavior; Behavior

Study Officials

• Ameerah Su'ad Abdul Shakor

  Universiti Teknologi Mara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ameerah Su'ad Abdul Shakor

CONTACT

+60332584000; ameerahsu3ad@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 6, 2024
• Study Start: June 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: Data will become available after the study results publication date and will remain accessible for up to 7 years following that date.
• Access Criteria: Permission must be obtained from Universiti Teknologi Mara, the Ministry of Health Malaysia, and the Department of Orang Asli Development before access to the IPD is granted. Other researchers interested in accessing the datasets must submit a request outlining the purpose of their research. The decision to share data will be based on the reasonableness and scientific merit of the request. Access is limited strictly to anonymized IPD underlying the published study results.

Locations

MY (2)