Development and Effectiveness of a New Intervention on Household Preparedness for Disease X and Outbreaks Among Orang Asli in Selangor: A Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Household Preparedness Score
研究概览
简要总结
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:
- Will the intervention package increase the level of preparedness for a Disease X and outbreaks among indigenous households in Selangor?
- Will the intervention improve the awareness and attitudes of the indigenous people in Selangor towards outbreak preparedness?
- 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:
- Participate in the activities in the newly developed intervention package, which would include workshops, simulation exercises, and card game play sessions.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Outbreak Preparedness Intervention for the Orang Asli (Behavioral)
Control
Randomly selected Orang Asli villages that will receive the educational brochures only.
干预措施: Educational Brochures for the Orang Asli (Behavioral)
结局指标
主要结局
Household Preparedness Score
时间窗: Before 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 Matrix
时间窗: Before 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.
次要结局
- 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))
研究者
Ameerah Su'ad binti Abdul Shakor
Principal Investigator
Universiti Teknologi Mara