Clinical trial NCT06539845: Creating a New Health Promotion Module to Help the Indigenous People of Selangor Prepare for Disease X and Outbreaks
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Universiti Teknologi Mara
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Malaysia
name: Universiti Putra Malaysia
name: Institute for Health Behavioural Research
name: Department of Orang Asli Development
First posted: 2024-08-06
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Household Preparedness Score
timeFrame: Before intervention (T0), immediately after the intervention (T1), 1-month follow-up (T2), and at a 2-months follow-up (T3)
measure: Household Preparedness Matrix
timeFrame: Before intervention (T0), immediately after the intervention (T1), 1-month follow-up (T2), and at a 2-months follow-up (T3)
Secondary outcomes:
measure: Cognitive Preparedness score
timeFrame: Before intervention (T0), immediately after the intervention (T1), 1-month follow-up (T2), and at a 2-months follow-up (T3)
measure: Preparedness Behaviour score
timeFrame: Before intervention (T0), immediately after the intervention (T1), 1-month follow-up (T2), and at a 2-months follow-up (T3)
Other outcomes:
Locations:
city: Gombak
country: Malaysia
facility: Pejabat JAKOA Daerah Gombak dan Petaling
state: Selangor
city: Gombak
country: Malaysia
facility: Pejabat JAKOA Daerah Gombak dan Petaling
state: Selangor
Study officials:
affiliation: Universiti Teknologi Mara
name: Ameerah Su'ad Abdul Shakor
role: PRINCIPAL_INVESTIGATOR
References: