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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06539845
Enrollment
96
Registered
2024-08-06
Start date
2025-06-30
Completion date
2025-09-30
Last updated
2025-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

BEHAVIORALOutbreak Preparedness Intervention for the Orang Asli

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.

BEHAVIORALEducational Brochures for the Orang Asli

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.

Sponsors

Ministry of Health, Malaysia
CollaboratorOTHER_GOV
Universiti Putra Malaysia
CollaboratorOTHER
Institute for Health Behavioural Research
CollaboratorUNKNOWN
Department of Orang Asli Development
CollaboratorUNKNOWN
Universiti Teknologi Mara
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Household Preparedness ScoreBefore 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 MatrixBefore 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

MeasureTime frameDescription
Cognitive Preparedness scoreBefore intervention (T0), immediately after the intervention (T1), 1-month follow-up (T2), and at a 2-months follow-up (T3)Measures the knowledge and attitude of participant regarding outbreak and Disease X 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 Knowledge and Attitude domain and normalized into a scale of 0 to 1.
Preparedness Behaviour scoreBefore intervention (T0), immediately after the intervention (T1), 1-month follow-up (T2), and at a 2-months follow-up (T3)Measures the current level of preparedness actions that has been done by participants. The score is derived from the total sum of marks gathered from each item within the Practice domain and normalized into a scale of 0 to 1.

Countries

Malaysia

Contacts

Primary ContactAmeerah Su'ad Abdul Shakor
ameerahsu3ad@gmail.com+60332584000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026