Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05863026
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-21
First Post:
2023-04-25
Brief Title:
Effectiveness of iDEAL in Improving the Knowledge Attitude Practice Environmental Cleanliness Index and Dengue Index
Sponsor:
Universiti Putra Malaysia
Organization:
Universiti Putra Malaysia
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
iDEAL
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 505430 cases in 2000 to 52 million in 2019 The total number of dengue cases in Malaysia has increased from merely 6543 cases in the year 1995 to 130101 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 005 and a confidence interval of 95 for hypothesis testing
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 005 and a confidence interval of 95 for hypothesis testing
Detailed Description:
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 505430 cases in 2000 to 52 million in 2019 The total number of dengue cases in Malaysia has increased from merely 6543 cases in year 1995 to 130101 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
Inclusion and exclusion criteria The inclusion criteria for this study are i Malaysian citizen ii standard 4 or form 4 from primary and secondary school respectively iii consented to participate in the study by parents or caregivers and iv consented by the school The exclusion criteria i not able to read Bahasa Malaysia or English ii physically or mentally impaired with disability card holder and iii temporary student as defined as less than 6 months during the study period
Sample size estimation The sample size calculation for this study was calculated based on the primary outcome desire which is knowledge on dengue prevention and control The sample size calculation was calculated using the formula for testing the different in proportion between two groups After adjustment for attrition rate of 70 from previous study the sample size needed for this study is 800 pairs of intervention and control groups which amount to 1600 participants
Sampling method and subject recruitment This study will use a multistage sampling technique The first stage of sampling will use proportionate sampling base on district in Selangor and Kuala Lumpur to select the 40 schools One classroom will be selected form each selected school Thus the second stage sampling will randomly select 20 standard 4 classrooms and 20 form 4 classrooms from selected primary and secondary school respectively All school children in selected classroom will be invited to participate in the study
Randomisation 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 11 basis in either the control or intervention group
Blinding This study will use the single blinding method in which the respondent will not be aware of their group status This type of blinding aims to minimize performance bias or also known as the Hawthorne effect in which the participant may change their responses or behaviour if they knew which group they were allocate in McCambridge et al 2014 It is not possible to blind the field researcher as they would be the one who will deliver the intervention module to the selected respondents
Research phase and tools This research protocol details the process of development implementation and effectiveness assessment of the 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 The study will be conducted over 24 months from June 2023 to May 2025 The study consists of three main phases which are Phase I Need assessment Phase II Development of Intervention module Phase III Implementation and effectiveness measurement
Phase I Need assessment Need assessment of the intervention will be conducted through combination approach of community diagnosis Assessment of the of current knowledge attitude and practice on dengue prevention and control will be via literature review survey Nominal Group Discussion NGD and Focus Group Discussion FGD among subject matter expert SME and stakeholder All information will be used for module development phase II to design the method and media of delivery content and assessment
Phase II Development of intervention module A systematic step-by-step procedure will be conducted for designing and developing the Theory Based Integrated Dengue Education Module
Phase III Implementation and effectiveness measurement The Implementation of final module will be conducted at selected school To ensure the standardisation of intervention trained researcher will conduct the intervention at selected school To ensure the standardisation pre-recorded video briefing and serial supervision by the main investigator will also be practiced throughout the intervention period Pre and post intervention questionnaire will be collected using validated self-administered questionnaires at four-time points T0 T1 T2 T3 to measure the effectiveness of the intervention module
Questionnaire
A self-administrated questionnaire in two language versions English and Malay in printed format will be used in this study The questionnaire used in the study is a new instrument that will be developed The questionnaire will be divided into five parts as below
Part 1 respondent information Consist of questions of sociodemographic data socioeconomic and history of dengue infection
Part 2 Knowledge on dengue prevention and control Part 3 Attitude on dengue prevention and control Part 4 Practice on dengue prevention and control Part 5 Environmental cleanliness index and Aedes index
Validity and reliability Content validity of the questionnaire will be assessed by Subject Matter Experts SME that include a public health medicine specialist family medicine physicians health educators occupational health doctor and occupational-related officer This evaluation will be performed by various agencies such as the Ministry of Health NIOSH DOSH SOCSO and Ministry of Higher education The content validation ratio CVR will be calculated to assess the acceptability of the questionnaire Furthermore the comments and feedback by the Subject Matter Experts SME will be taken into consideration for further correction of the questionnaire In addition the Content Validity Index CVI will be calculated to assess the relevance and clarity of the questionnaire by the assigned experts Following that the Item CVI I-CVI and the scale average CVI S-CVIAve will be calculated The questionnaire will then be modified according to the agreement level of the experts based on the calculated CVI
The reliability of the instrument will be measured using internal consistency method calculated in IBM SPSS Version 28
Data collection After the initiation of the study consent will be obtained by the liaison officer from school children who fulfil the eligibility criteria Subsequently baseline data T0 will be obtained from school children who consented to join the study Those subject who consented to join the study and will be allocated in the intervention group will be given appointment within 1 month for delivering of intervention package according to class The total duration of intervention session will be around 30 minutes for 3 series of meeting After completion of intervention the school children will be asked to answer the post intervention assessment measuring outcome of the study immediately T1 one month T2 and three months T3 The control group will undergo the same assessment as the intervention group at baseline T1 T2 and T3 T
Ethics approval and consent to participate This study has been approved by the Ethics Committee for Research Involving Human Subjects of Universiti Putra Malaysia JKEUPM-2023-347 All participants will be informed that their enrolment will in no way affect their relationship with their teacher Consent from each participant parents or caregiver will be obtained using a consent form upon agreement to participate in the study before answering the baseline questionnaire Participants are allowed to withdraw at any point during the study
Consent for publication and dissemination Consent from the participants for publication will be obtained from the same consent for participation The results will be reported and presented in international peer-reviewed journals conferences and other platforms No personnel or school information will be disclosed in the dissertation writing and other published manuscript
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
Inclusion and exclusion criteria The inclusion criteria for this study are i Malaysian citizen ii standard 4 or form 4 from primary and secondary school respectively iii consented to participate in the study by parents or caregivers and iv consented by the school The exclusion criteria i not able to read Bahasa Malaysia or English ii physically or mentally impaired with disability card holder and iii temporary student as defined as less than 6 months during the study period
Sample size estimation The sample size calculation for this study was calculated based on the primary outcome desire which is knowledge on dengue prevention and control The sample size calculation was calculated using the formula for testing the different in proportion between two groups After adjustment for attrition rate of 70 from previous study the sample size needed for this study is 800 pairs of intervention and control groups which amount to 1600 participants
Sampling method and subject recruitment This study will use a multistage sampling technique The first stage of sampling will use proportionate sampling base on district in Selangor and Kuala Lumpur to select the 40 schools One classroom will be selected form each selected school Thus the second stage sampling will randomly select 20 standard 4 classrooms and 20 form 4 classrooms from selected primary and secondary school respectively All school children in selected classroom will be invited to participate in the study
Randomisation 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 11 basis in either the control or intervention group
Blinding This study will use the single blinding method in which the respondent will not be aware of their group status This type of blinding aims to minimize performance bias or also known as the Hawthorne effect in which the participant may change their responses or behaviour if they knew which group they were allocate in McCambridge et al 2014 It is not possible to blind the field researcher as they would be the one who will deliver the intervention module to the selected respondents
Research phase and tools This research protocol details the process of development implementation and effectiveness assessment of the 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 The study will be conducted over 24 months from June 2023 to May 2025 The study consists of three main phases which are Phase I Need assessment Phase II Development of Intervention module Phase III Implementation and effectiveness measurement
Phase I Need assessment Need assessment of the intervention will be conducted through combination approach of community diagnosis Assessment of the of current knowledge attitude and practice on dengue prevention and control will be via literature review survey Nominal Group Discussion NGD and Focus Group Discussion FGD among subject matter expert SME and stakeholder All information will be used for module development phase II to design the method and media of delivery content and assessment
Phase II Development of intervention module A systematic step-by-step procedure will be conducted for designing and developing the Theory Based Integrated Dengue Education Module
Phase III Implementation and effectiveness measurement The Implementation of final module will be conducted at selected school To ensure the standardisation of intervention trained researcher will conduct the intervention at selected school To ensure the standardisation pre-recorded video briefing and serial supervision by the main investigator will also be practiced throughout the intervention period Pre and post intervention questionnaire will be collected using validated self-administered questionnaires at four-time points T0 T1 T2 T3 to measure the effectiveness of the intervention module
Questionnaire
A self-administrated questionnaire in two language versions English and Malay in printed format will be used in this study The questionnaire used in the study is a new instrument that will be developed The questionnaire will be divided into five parts as below
Part 1 respondent information Consist of questions of sociodemographic data socioeconomic and history of dengue infection
Part 2 Knowledge on dengue prevention and control Part 3 Attitude on dengue prevention and control Part 4 Practice on dengue prevention and control Part 5 Environmental cleanliness index and Aedes index
Validity and reliability Content validity of the questionnaire will be assessed by Subject Matter Experts SME that include a public health medicine specialist family medicine physicians health educators occupational health doctor and occupational-related officer This evaluation will be performed by various agencies such as the Ministry of Health NIOSH DOSH SOCSO and Ministry of Higher education The content validation ratio CVR will be calculated to assess the acceptability of the questionnaire Furthermore the comments and feedback by the Subject Matter Experts SME will be taken into consideration for further correction of the questionnaire In addition the Content Validity Index CVI will be calculated to assess the relevance and clarity of the questionnaire by the assigned experts Following that the Item CVI I-CVI and the scale average CVI S-CVIAve will be calculated The questionnaire will then be modified according to the agreement level of the experts based on the calculated CVI
The reliability of the instrument will be measured using internal consistency method calculated in IBM SPSS Version 28
Data collection After the initiation of the study consent will be obtained by the liaison officer from school children who fulfil the eligibility criteria Subsequently baseline data T0 will be obtained from school children who consented to join the study Those subject who consented to join the study and will be allocated in the intervention group will be given appointment within 1 month for delivering of intervention package according to class The total duration of intervention session will be around 30 minutes for 3 series of meeting After completion of intervention the school children will be asked to answer the post intervention assessment measuring outcome of the study immediately T1 one month T2 and three months T3 The control group will undergo the same assessment as the intervention group at baseline T1 T2 and T3 T
Ethics approval and consent to participate This study has been approved by the Ethics Committee for Research Involving Human Subjects of Universiti Putra Malaysia JKEUPM-2023-347 All participants will be informed that their enrolment will in no way affect their relationship with their teacher Consent from each participant parents or caregiver will be obtained using a consent form upon agreement to participate in the study before answering the baseline questionnaire Participants are allowed to withdraw at any point during the study
Consent for publication and dissemination Consent from the participants for publication will be obtained from the same consent for participation The results will be reported and presented in international peer-reviewed journals conferences and other platforms No personnel or school information will be disclosed in the dissertation writing and other published manuscript
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None