Creating a New Health Promotion Module to Help the Indigenous People of Selangor Prepare for Disease X and Outbreaks
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Outbreak Preparedness Intervention for the Orang Asli, Educational Brochures for the Orang Asli.
- Who it may be relevant to
- Registry conditions: Attitude to Health, Behavior, Health, Health Behavior, Health-Related Behavior. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Malaysia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development and Effectiveness of a New Intervention on Household Preparedness for Disease X and Outbreaks Among Orang Asli in Selangor: A Cluster Randomized Trial
Overview
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
- Behavioral 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. - 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.
Primary outcome measures
- 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)]
- 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)]
Secondary outcome measures (2)
- Cognitive 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)]
- Preparedness Behaviour score [Time frame: Before intervention (T0), immediately after the intervention (T1), 1-month follow-up (T2), and at a 2-months follow-up (T3)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Malaysia · 2 centers
- Pejabat JAKOA Daerah Gombak dan Petaling — Gombak
- Pejabat JAKOA Daerah Gombak dan Petaling — Gombak
Identifiers
NCT: NCT06539845 · 24-01859-NQ7