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Trial registered on ANZCTR


Registration number
ACTRN12623000388617p
Ethics application status
Submitted, not yet approved
Date submitted
5/04/2023
Date registered
18/04/2023
Date last updated
18/04/2023
Date data sharing statement initially provided
18/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of an evidence-based health education program for parents of children undergoing congenital heart disease (CHD) surgery in Vietnam: The main study.
Scientific title
A two-group quasi-experimental study investigating the impact of a health education intervention to improve CHD knowledge for parents of affected children at the post-operative phase in Vietnam (Phase 2).
Secondary ID [1] 309384 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congenital heart disease 329611 0
Condition category
Condition code
Cardiovascular 326538 326538 0 0
Other cardiovascular diseases
Surgery 326539 326539 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a evidence-based health education program which includes five training sessions with support of parent hard copy resources. Parents in the intervention group will receive standard care, which will be subsequently described in the next question and additional health education from this program.

First, parents will receive general disease specific knowledge in a face-to-face training session on the day of their child's admission (Week 1), which lasts approximately 100 minutes in a predicted group size from 4-5 parents.

One week after surgery (Week 2), a one-on-one bedside training session will provide these parents with recommended disease specific management behaviours, for example common medications that their children will be discharged on, the recognition of deterioration and nutritional needs. This session is about 30-45 minutes long.

Two weeks after surgery (Week 3), parents will receive the second one-on-one bedside training session which is the same as in the first one with different topics such as prevention of infective endocarditis and wound care.

Two weeks after hospital discharge (Week 5 or Week 6), parents will be provided with the first 20-minute one-on-one follow-up training session focusing on medication adherence, signs of deterioration and nutritional needs. The session may be implemented via in-person interactions if the parents take their child to outpatient appointments after surgery. Alternatively, it can be via phone calls if they do not attend their child's outpatient appointment.

Finally, at six weeks after discharge (Week 9 or Week 10), the process will be the same as two weeks after discharge, which was previously described.

The teach-back health education method will be applied for all one-on-one training sessions to promote parents' comprehension of given knowledge. Parent hard copy resources are developed to support health education by the principal researcher and reviewed by the supervisory team. Parents will be provided with these resources at the face-to-face group training session for their review during hospitalisation and at home.

The principal researcher, who is also a nursing staff in the Heart Center, the research setting, will provide health education to intervention group parents. A health education checklist is designed to ensure the intervention fidelity. The checklist includes a list of key knowledge elements that guide the principal researcher to focus on in each session. Elements that are delivered to parents will be ticked in the appropriate boxes while elements that have not been provided will be noted to inform subsequent training sessions. The use of checklist will also facilitate the principal researcher to provide an equal education intervention for each parent.
Intervention code [1] 325820 0
Treatment: Other
Comparator / control treatment
Standard care/Control group parents will receive 15-minute standard care education provided by on-duty doctors and nurses in the Heart Center at their children’s discharge (verbal explanations with no parent hard copy resources). Standard care education consists of general instructions which are largely about medication administration and the child's schedule for outpatient appointments. Standard care education is inconsistent between healthcare staff and largely relies on their training backgrounds and experience in medicine or nursing. No follow-up education is provided after discharge.
Control group
Active

Outcomes
Primary outcome [1] 334386 0
The primary outcome is parents' CHD knowledge which is evaluated using the Vietnamese parent Leuven Knowledge Questionnaire for Congenital Heart Disease (LKQCHD). The 23-item instrument, which includes multiple choice questions and multiple answer questions, has been validated in the study population. The data will be collected by an assessor who reads the questions to parents (both the intervention and control groups) and notes their responses.
Timepoint [1] 334386 0
Time point 1: At baseline by the principal researcher.
Time point 2: Hospital discharge by the research assistants.
Time point 3: Two weeks after discharge by the research assistants.
Time point 4: Six weeks after discharge by the research assistants..
Secondary outcome [1] 420458 0
Children's health outcomes will be assessed as a composite secondary outcome.

Children's health outcomes, which include clinical data such as oxygen saturation and left ventricular ejection fraction and major social changes, for example changes in primary caregivers. The Child Health Outcome Form was developed by the principal researcher to collect this data. Clinical data will be collected by reviewing children's medical records while major social changes will be assessed by asking parents and noting their responses.
Timepoint [1] 420458 0

Time point 1: At baseline by the principal researcher.
Time point 2: Hospital discharge by the research assistants.
Time point 3: Two weeks after discharge by the research assistants.
Time point 4: Six weeks after discharge by the research assistants.

Eligibility
Key inclusion criteria
Participants in this study (Phase 2), who are dyads of parents and their children, will be selected using the eligibility criteria as follows.
Inclusion criteria:

Parents who are primary caregivers and have Vietnamese language literacy,
Their child is aged 0 to 5 years, 11mths of age and undergoing CHD surgery categorised by the Risk Adjustment classification for Congenital Heart Surgery (RACHS-1) from 1-6.

Parents are primary participants of the study who receive additional health education. Their below age range will be presented in the next section. Children are secondary participants whose data such as clinical data and major social changes will be collected facilitating the principal researcher to accurately evaluate the effect of the education intervention.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children who have complex chromosomal arrangements, other major comorbidities, or birth complications.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed in this study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Due to a long hospital stay post heart surgery and the open ward infrastructure, parents have many opportunities to share ideas and experiences leading to risks of intervention/control group contamination. Hence, randomisation of parents at the same time to both intervention and control group for extended periods is impractical in this study. As a result, the recruitment of parents in the two groups will be implemented by blocks of time to limit intervention contamination.

Participants in this study (Phase 2) will be recruited by time period. First, control group dyads of parents and children will be recruited and then followed by a two-week wash-out period. After that, intervention group dyads will be recruited. It may take approximate six weeks to complete the recruitment of each group (intervention and control group).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
A two-week wash-out period will be implemented between the completion of recruiting control group dyads and starting recruitment of intervention group dyads for the Phase 2 study. The purpose of this wash-out period is to ensure that the last control group dyads will be discharged from the hospital before the intervention group dyads arrive in the ward. Hence, it helps to limit intervention/control group interactions and reduces intervention contamination.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size

The study (Phase 2) sample size will be calculated by using an effect size of .5 and considering 80% power and a type 1 error rate (alpha) of .05 (two-tailed). A sample size of 128 participants in the two groups may be required. With an assumption of 15% attrition rate, the estimated sample size will be 148 participants for the two groups. Adjustments will be made based on results from Phase 1.

Statistical methods

Chi square or Fisher Exact test for categorical variables,
Pair t-test for intragroup comparisons of continuous data,
Independent t-test or Mann-Whitney U tests for intergroup two-mean comparisons,
A one-way analysis of variance (ANOVA) for intergroup comparisons of more than two means.
Group-wise linear regression to examine the predictor.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/06/2023
Actual
Date of last participant enrolment
Anticipated
1/10/2023
Actual
Date of last data collection
Anticipated
12/11/2023
Actual
Sample size
Target
148
Accrual to date
Final
Recruitment outside Australia
Country [1] 25379 0
Viet Nam
State/province [1] 25379 0
Hanoi

Funding & Sponsors
Funding source category [1] 313579 0
University
Name [1] 313579 0
Queensland University of Technology Research Award (QUTPRA (International) and QUT HDR Tuition Fee Sponsorship
Country [1] 313579 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Victoria Park Road, Kelvin Grove
Brisbane, Queensland, QLD 4059
Country
Australia
Secondary sponsor category [1] 315365 0
Hospital
Name [1] 315365 0
Vietnam National Children's Hospital
Address [1] 315365 0
18/879 La Thanh, Dong Da, Hanoi, Vietnam
Country [1] 315365 0
Viet Nam

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312759 0
Queensland University of Technology Human Research Ethics Committee
Ethics committee address [1] 312759 0
Office of Research Ethics and Integrity: Human research ethics
Level 4, X block, Kelvin Grove
Brisbane, QLD 4059
Ethics committee country [1] 312759 0
Australia
Date submitted for ethics approval [1] 312759 0
30/03/2023
Approval date [1] 312759 0
Ethics approval number [1] 312759 0

Summary
Brief summary
This study aims to examine the effectiveness of an evidence-based health education program on parents' congenital heart disease (CHD) knowledge and their children's health outcomes after surgery. The expected outcomes are the improvement of parents' CHD knowledge after participating in the program, which in turn will increase their affected child's health outcomes,
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125806 0
Mrs Tran Thi Mai Huong
Address 125806 0
Room 602, 6th floor, N block, Kelvin Grove campus
School of Nursing, Faculty of Health
Queensland University of Technology
Victoria Park road, Kelvin Grove
Brisbane, QLD 4059
Country 125806 0
Australia
Phone 125806 0
+61 731388621
Fax 125806 0
Email 125806 0
thaimaihuong.tran@hdr.qut.edu.au
Contact person for public queries
Name 125807 0
Mrs Tran Thi Mai Huong
Address 125807 0
Room 602, 6th floor, N block, Kelvin Grove campus
School of Nursing, Faculty of Health
Queensland University of Technology
Victoria Park road, Kelvin Grove
Brisbane, QLD 4059
Country 125807 0
Australia
Phone 125807 0
+61 731388621
Fax 125807 0
Email 125807 0
thaimaihuong.tran@hdr.qut.edu.au
Contact person for scientific queries
Name 125808 0
Mrs Tran Thi Mai Huong
Address 125808 0
Room 602, 6th floor, N block, Kelvin Grove campus
School of Nursing, Faculty of Health
Queensland University of Technology
Victoria Park road, Kelvin Grove
Brisbane, QLD 4059
Country 125808 0
Australia
Phone 125808 0
+61 731388621
Fax 125808 0
Email 125808 0
thaimaihuong.tran@hdr.qut.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only aggregate data of this study will be available because of the following reason.

The study data includes sensitive outcomes of heart surgery in the Heart Center, for example unanticipated medical conditions/adverse events. Hence, the Heart Center has their own strict policy regarding data sharing that requires all researchers who collect data there to follow. The principal researcher will ask an approval from the Heart Center prior to sharing any aggregate data as requested.


What supporting documents are/will be available?




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.