Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000582550
Ethics application status
Approved
Date submitted
6/01/2015
Date registered
3/06/2015
Date last updated
25/11/2019
Date data sharing statement initially provided
25/11/2019
Date results information initially provided
25/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Developing Children Asthma Program (CAP) in promoting health outcomes among school children
Scientific title
Effect of the Children Asthma Program (CAP) on level of asthma knowledge among school children with asthma and their caregivers
Secondary ID [1] 285422 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 293175 0
Condition category
Condition code
Respiratory 293452 293452 0 0
Asthma
Public Health 294528 294528 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Children Asthma Program will be implemented to provide education activities to promote the prevention of recurrent and management of asthma among the school children. School children will be divided to two groups ( intervention group and control group )
The intervention group they will receive face to face class room learning. Only one session face to face learning will be given to students for 1 hour. Following the face to face learning online mobile learning will be administer for 3 months which will be electronic alternative for hand workbook tool, the frequency and duration of use of the mobile application it will be flexible and according to user prefer to use it during 3 months.
The parents of children will not receive face to face education only we will give them clarifying session about using mobile application and how to using it to help their children in dealing with mobile application
Baseline data will be collected before the intervention one month after intervention and at third month.
Intervention code [1] 290341 0
Prevention
Intervention code [2] 291196 0
Behaviour
Comparator / control treatment
The control group will met for session delivered one time take one session for both children and parents in the same time for face to face lecture about the asthma and they will take hand workbook will be designed to be colorful, entertaining, educational, and developmentally appropriate as well as diverse in regards to gender, race, and culture. The content of the workbook includes anatomy and physiology of the lungs, management, and prevention of disease.

The control group the school children, they will support through 3-hours information-sharing program. The CAP will be presented asthma content to the parents follow by questions and answer. The Q&A session leading to increase asthma knowledge, logical reasoning abilities for managing acute episodes, use of effective asthma health behaviors, and acceptance of asthma, and an overview of coalition activities will be presented. Presentation will be limit to 90 minutes then the Q & A will take around 60 - 90 minutes. Hands-outs of the content will be provided.
Control group
Active

Outcomes
Primary outcome [1] 293271 0
1) Level of knowledge on asthma among school children and caregivers using Knowledge of Asthma Survey
Timepoint [1] 293271 0
Baseline before intervention, 1st month, then third month post intervention.
Secondary outcome [1] 310698 0
School children problems solving and decisions making regarding management of asthma using Reasoning about Asthma Scenarios
Timepoint [1] 310698 0
Baseline before intervention, 1st month, then third month post intervention.
Secondary outcome [2] 312174 0
School children’s level of acceptance on asthma using Acceptance of Asthma Questionnaire
Timepoint [2] 312174 0
Baseline before intervention, 1st month, then third month post intervention.
Secondary outcome [3] 312175 0
Behaviour change among school children using Asthma Health Behaviours Survey
Timepoint [3] 312175 0
Baseline before intervention, 1st month, then third month post intervention.
Secondary outcome [4] 312176 0
Participation in life activities among school children using Participation in Life Activities questions
Timepoint [4] 312176 0
Baseline before intervention, 1st month, then third month post intervention.
Secondary outcome [5] 312177 0
Incidence rate of recurrent of asthma, measure by check the medical history for the frequency visiting of health care services due to asthma.
Timepoint [5] 312177 0
Baseline before intervention 1 month, then third month after intervention.
Secondary outcome [6] 313003 0
Lung capacity (peak flow reading).
Timepoint [6] 313003 0
Baseline before intervention 1 month, then third month after intervention.

Eligibility
Key inclusion criteria
School children:
1) known case of asthma
2) availability to participate in scheduled classes sessions
3) able to understand and communicate in Malay or English

Family caregiver:
1) being a designated caregiver of school children with asthma
2) able to understand English or Malay
3) willing to attend and participate in the community component
Minimum age
13 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
School children or caregivers who are unwilling to participate.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/03/2015
Actual
15/04/2015
Date of last participant enrolment
Anticipated
31/12/2015
Actual
5/02/2016
Date of last data collection
Anticipated
Actual
27/05/2016
Sample size
Target
700
Accrual to date
Final
340
Recruitment outside Australia
Country [1] 6383 0
Malaysia
State/province [1] 6383 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 290026 0
University
Name [1] 290026 0
University of Malaya Research Grant
Country [1] 290026 0
Malaysia
Primary sponsor type
Individual
Name
Dr.Chong Mei Chan
Address
Department of Nursing Sciences
Faculty of Medicine
University of Malaya
50603 Kuala Lumpur, Malaysia
Country
Malaysia
Secondary sponsor category [1] 288718 0
None
Name [1] 288718 0
Address [1] 288718 0
Country [1] 288718 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304810 0
UMMC
Ethics committee address [1] 304810 0
Kuala Lumpur, Federal Territory of Kuala Lumpur
Ethics committee country [1] 304810 0
Malaysia
Date submitted for ethics approval [1] 304810 0
30/11/2016
Approval date [1] 304810 0
10/03/2017
Ethics approval number [1] 304810 0
2016112-4501

Summary
Brief summary
A prospective, longitudinal, cluster randomized clinical trial involving two-group , will be used to evaluate the outcome of Children Asthma Program (CAP).
Trial website
Trial related presentations / publications
Public notes
The University of Malaya new policy to register all the health research project under UMMC ethical committee to fulfillment despite the permission taken by Ministry.
The nature of this study is educational and training study and not involve any medical intervention to patient, so it can be allowed to get ethical approval retrospective just to register our study in the university database.

Contacts
Principal investigator
Name 51794 0
Dr Chong Mei Chan
Address 51794 0
Department of Nursing Science,
Faculty of Medicine,
University of Malaya,
50603 Kuala Lumpur,
Malaysia.
Country 51794 0
Malaysia
Phone 51794 0
+603-79493675
Fax 51794 0
Email 51794 0
mcchong@um.edu.my
Contact person for public queries
Name 51795 0
Dr Chong Mei Chan
Address 51795 0
Department of Nursing Science,
Faculty of Medicine,
University of Malaya,
50603 Kuala Lumpur,
Malaysia.
Country 51795 0
Malaysia
Phone 51795 0
+603-79493675
Fax 51795 0
Email 51795 0
mcchong@um.edu.my
Contact person for scientific queries
Name 51796 0
Dr Chong Mei Chan
Address 51796 0
Department of Nursing Science,
Faculty of Medicine,
University of Malaya,
50603 Kuala Lumpur,
Malaysia.
Country 51796 0
Malaysia
Phone 51796 0
+603-79493675
Fax 51796 0
Email 51796 0
mcchong@um.edu.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5852Ethical approval    367184-(Uploaded-21-11-2019-18-21-07)-Study-related document.jpeg
5853Informed consent form  mcchong@um.edu.my



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.