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

NCT ID: NCT06539845

Last Updated: 2025-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Outbreak Preparedness Intervention for the Orang Asli

Intervention Type 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.

Control

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

Group Type ACTIVE_COMPARATOR

Educational Brochures for the Orang Asli

Intervention Type 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.

Interventions

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Outbreak 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.

Intervention Type BEHAVIORAL

Educational 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Health, Malaysia

OTHER_GOV

Sponsor Role collaborator

Universiti Putra Malaysia

OTHER

Sponsor Role collaborator

Institute for Health Behavioural Research

UNKNOWN

Sponsor Role collaborator

Department of Orang Asli Development

UNKNOWN

Sponsor Role collaborator

Universiti Teknologi Mara

OTHER

Sponsor Role lead

Responsible Party

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Ameerah Su'ad binti Abdul Shakor

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ameerah Su'ad Abdul Shakor

Role: PRINCIPAL_INVESTIGATOR

Universiti Teknologi Mara

Locations

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Pejabat JAKOA Daerah Gombak dan Petaling

Gombak, Selangor, Malaysia

Site Status ENROLLING_BY_INVITATION

Pejabat JAKOA Daerah Gombak dan Petaling

Gombak, Selangor, Malaysia

Site Status RECRUITING

Countries

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Malaysia

Central Contacts

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Ameerah Su'ad Abdul Shakor

Role: CONTACT

+60332584000

Facility Contacts

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Pejabat JAKOA Daerah Gombak dan Petaling

Role: primary

+60361871080

Other Identifiers

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24-01859-NQ7

Identifier Type: -

Identifier Source: org_study_id

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