Effectiveness of Theory Based Integrated Dengue Education and Learning Module (iDEAL) in Improving the Knowledge, Attitude, Practice, Environmental Cleanliness Index and Dengue Index Among School Children: Study Protocol for a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,600
- 试验地点
- 1
- 主要终点
- change of knowledge
研究概览
简要总结
Background Dengue is a mosquito-borne viral disease caused by four distinct but closely related dengue virus (DENV). The incidence of dengue has grown dramatically worldwide in recent decades, with cases reported to WHO increased from 505,430 cases in 2000 to 5.2 million in 2019. The total number of dengue cases in Malaysia has increased from merely 6,543 cases in the year 1995 to 130,101 cases in the year 2019. Knowledge, attitude and practice remain the most effective driving tool against dengue prevention and control and it becomes very necessary to plan an integrated module for the primary prevention of dengue infection especially among school children.
Aims The present study intends to develop, implement and evaluate the effectiveness of theory-based integrated dengue education module in improving the knowledge, attitude, practice, environmental cleanliness index, and dengue index among school children in Selangor and Kuala Lumpur.
Methods This study is a single-blinded, cluster randomized controlled trial study, expected to be conducted from 1st June 2023 to 31st May 2025 among 20 primary dan 20 secondary schools in Selangor and Kuala Lumpur. The respondents will be allocated into intervention and control groups randomly based on selected clusters to avoid contamination. The intervention group will receive IDEM, while the control group will receive standard education. The outcome will be measured using validated, self-administered questionnaires at four time points: baseline (T0), Immediately (T1), one month (T2), and three months (T3) post-intervention to measure the effectiveness of the intervention module. The data will be analysed using IBM Statistical Package for Social Science (SPSS) version 28 involving descriptive and inferential statistics. The Generalized Linear Mixed Model (GLMM) will be used to test the main effect and interaction between and within the intervention and control groups over time at T0, T1, T2 and T3. This study will use a significance level with a p-value of 0.05 and a confidence interval of 95% for hypothesis testing
详细描述
Introduction Dengue is a mosquito-borne viral disease caused by four distinct but closely related dengue virus (DENV) serotypes. The incidence of dengue has grown dramatically around the world in recent decades, with cases reported to WHO increased from 505,430 cases in 2000 to 5.2 million in 2019. The total number of dengue cases in Malaysia has increased from merely 6,543 cases in year 1995 to 130,101 cases in year 2019. Knowledge, attitude and behaviour change remain the most effective driving tool against dengue infection and it becomes very necessary to plan an integrated module for primary prevention of dengue infection especially among school children. School-based health education is a crucial tool to enhance knowledge and raise awareness of the seriousness of dengue among school children, and to transfer knowledge and practices from classrooms to homes. The present study intends to develop, implement and evaluate the effectiveness of theory based integrated dengue education module in improving the knowledge, attitude, practice, environmental index and dengue index among school children in Selangor and Kuala Lumpur.
Methods Study design This is a two-arm randomised, single blinded, controlled, parallel, trial.
Study duration The study will be conducted over a period of 24 months, from 1st September 2023 until 31st August 2025, with data collection will be commenced on 1st November 2023.
Study location The study will be conducted in Selangor and Kuala Lumpur.
Study population This study will be carried out in primary and secondary school under supervision of Ministry of Education (MOE). The study participants will be students standard four and form four school children from government primary and secondary school in Selangor and Kuala Lumpur.
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)
盲法说明
Allocation concealment In this study, the allocation concealment method that will be use is the "sequentially numbered, opaque, sealed enveloped methods".
This study will use the single blinding method in which the respondent will not be aware of their group status.
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Malaysian citizen,
- •standard 4 or form 4 from primary and secondary school respectively,
- •consented to participate in the study by parents or caregivers,
- •consented by the school. The
排除标准
- •Exclusion Criteria:
- •not able to read Bahasa Malaysia or English,
- •physically or mentally impaired with disability card holder,
- •temporary student as defined as less than 6 months during the study period.
研究组 & 干预措施
iDEAL group
School cluster randomization will be used to ensure administrative efficacy, lessened risk of experimental contamination, and enhancement of subject compliance. 20 standard 4 classrooms and 20 form 4 classrooms from primary and secondary school, then will be divided randomly into intervention and control group. The unit of randomization will be on a 1:1 basis in either the control or intervention group.
干预措施: THEORY BASED INTEGRATED DENGUE EDUCATION AND LEARNING MODULE (iDEAL) (Behavioral)
Control
School cluster randomization will be used to ensure administrative efficacy, lessened risk of experimental contamination, and enhancement of subject compliance. 20 standard 4 classrooms and 20 form 4 classrooms from primary and secondary school, then will be divided randomly into intervention and control group. The unit of randomization will be on a 1:1 basis in either the control or intervention group.
结局指标
主要结局
change of knowledge
时间窗: baseline (T0), immediately post-intervention (T1), one month (T2), and three months (T3) post-intervention
knowledge score change compare to baseline the unabbreviated scale title: knowledge Score the minimum and maximum values: 15, 75 higher scores mean a better outcome.
change of attitude
时间窗: baseline (T0), immediately post-intervention (T1), one month (T2), and three months (T3) post-intervention
attitude score change compare to baseline the unabbreviated scale title: Attitude Score the minimum and maximum values: 15, 75 higher scores mean a better outcome.
change of practice
时间窗: baseline (T0), immediately post-intervention (T1), one month (T2), and three months (T3) post-intervention
practice score change compare to baseline the unabbreviated scale title: Practice Score the minimum and maximum values: 15, 75 higher scores mean a better outcome.
次要结局
- change of Environmental cleanliness index(baseline (T0), immediately post-intervention (T1), one month (T2), and three months (T3) post-intervention)
- change of Aedes index the unabbreviated scale title: Aedes index the minimum and maximum values: 0, 1 higher scores mean a worse outcome.(baseline (T0), immediately post-intervention (T1), one month (T2), and three months (T3) post-intervention)
研究者
Rahmat bin Dapari
Principal Investigator
Universiti Putra Malaysia