Effectiveness of iDEAL in Improving the Knowledge, Attitude, Practice, Environmental Cleanliness Index and Dengue Index

NCT05863026 | Unknown

• 1 other identifier: iDEAL
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Knowledge, Attitudes, Practice

Keywords

Knowledge, Attitudes, Practice

Outcome Measures

Primary Outcomes (3)

• change of knowledge

  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.

  baseline (T0), immediately post-intervention (T1), one month (T2), and three months (T3) post-intervention

• change of attitude

  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.

  baseline (T0), immediately post-intervention (T1), one month (T2), and three months (T3) post-intervention

• change of practice

  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.

  baseline (T0), immediately post-intervention (T1), one month (T2), and three months (T3) post-intervention

Secondary Outcomes (2)

• 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

Study Arms (2)

iDEAL group

EXPERIMENTAL

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.

Behavioral: THEORY BASED INTEGRATED DENGUE EDUCATION AND LEARNING MODULE (iDEAL)

Control

NO INTERVENTION

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.

Interventions

THEORY BASED INTEGRATED DENGUE EDUCATION AND LEARNING MODULE (iDEAL) BEHAVIORAL

THEORY BASED INTEGRATED DENGUE EDUCATION AND LEARNING MODULE (iDEAL)

iDEAL group

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Malaysian citizen,
• standard 4 or form 4 from primary and secondary school respectively,
• consented to participate in the study by parents or caregivers,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Putra Malaysia: lead
• Takeda Malaysia Sdn. Bhd.: collaborator

Study Sites (1)

Universiti Putra Malaysia

Serdang, Selangor, 43400, Malaysia

Location

MeSH Terms

Conditions

Behavior

Study Officials

• Rahmat Dapari, DrPH

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rahmat Dapari, DrPH

CONTACT

+60192322815; drrahmat@upm.edu.my

Kalaivani Muniandy, Master

CONTACT

+60162805898; kalai_kl.town@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a two-arm randomised, single blinded, controlled, parallel, trial. This study will recruit and randomise school children into intervention group and control group based on selected school to avoid contamination.

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 17, 2023
• Study Start: November 1, 2023
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: July 21, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)