Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000388617
Ethics application status
Approved
Date submitted
5/04/2023
Date registered
18/04/2023
Date last updated
18/07/2024
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 adjustments for Phase 2

The sample size is determined based on the findings of the pilot study conducted in Phase 1, utilising GPower 3.1. The primary outcome of interest is parental CHD knowledge score. In the pilot study, the mean difference in parental CHD knowledge scores at baseline and the second outpatient appointment time point (Time 2) between the intervention group and control group was high (M = 6.7 points, t(18) = 3.4, 95% CI: 2.6, 10.8). Consequently, the Phase 2 analysis requires a smaller sample size to detect variations in parental CHD knowledge scores than originally forecast using prior research studies (Staveski et al., 2016). Specifically, applying a very large effect size of 1.5 (equivalent to the differences detected in mean parental CHD knowledge scores of 6.7 points), 80% power, and a two-tailed type 1 error rate (alpha) of 0.05, a sample size of 16 dyads of parents and their children (8 dyads/group) is necessary.

Given the considerable differences in parental CHD knowledge scores between the two groups detected, the project will take an additional step and investigate changes in children's health outcomes after CHD surgery between the two groups, for example child weight gain as detected in a previous study (Zhang et al., 2022). In the pilot study, the child’s weight was collected at two time points: baseline and at Time 2 giving a variable of percentage weight gain - baseline to time 2. Median percentage weight gain was calculated for both groups. The median percentage weight gain in the intervention group was 30.6% (IQR: 15.0-45.9), indicating a clinical increase of 18.5% when compared to the median percentage weight gain in the control group (Median = 12.1%, IQR: 7.3-20.2).
The sample size in Phase 2 is expected to be larger, and it is anticipated that the data will follow a normal distribution. Given the small size of 20 parent-child dyads in the pilot study, the pooled standardized deviation of the entire sample was used to predict the mean distribution in a larger sample size. The mean percentage weight gain (baseline to Time 2) and the pooled standard deviation from the pilot study was used to calculate an effect size for Phase 2 sample size. Specifically, the mean percentage weight gain in the intervention group (34.3%), in the control group (16%), and the pooled standard deviation of 22.2% resulted in a large effect size of 0.8. Considering 80% power and a two-tailed type 1 error rate (alpha) of 0.05, a sample size of 50 dyads consisting of parents and their children (25 dyads/group) was deemed necessary.

Some concerns have been raised regarding the utilisation of the large effect size of 0.8. Firstly, differences in age between the two groups in the pilot study might affect weight gain. The median age of children in the intervention group was 4.5 months (IQR: 2.0-12.0), which was lower than that of the control group (Median = 18.5 months, IQR: 6.5-52.5). Theoretically, a younger group would experience a greater weight gain (as percentage weight gain) compared to an older group. Secondly, the unique demands of each surgical procedure necessitate small variances in the schedule of outpatient appointments which were observed from discharge to Time 2, both within and between the two groups. This predicted difference in the time that has elapsed since a child’s discharge to when a child returns to their second outpatient appointment also influences the child’s weight gain. Therefore, a medium effect size was selected to increase the statistical power for detecting differences between the two groups. This effect size also assists in managing potential variations in the ages of children, outpatient appointment schedules, and the baseline weight within groups.

With 80% power, a two-tailed type 1 error rate (alpha) of 0.05 and a medium effect size of 0.5, a sample size of 128 dyads (64 dyads/group) was used. Considering a 15% attrition rate, the estimated sample size is 148 dyads, equally distributed between the two groups (74 dyads/group). This sample size aligns with the common rule of thumb, which typically recommends 10-20 observations per independent variable, for the linear mixed model to adjust for the effects of age and the time elapsed to outpatient appointments on child weight gain.

Unusually, during the recruitment of control group participants for Phase 2, a low attrition rate (0%) was observed with complete data sets for 74 recruited dyads. This feature in the study cohort has been reported previously (Nguyen et al., 2019; Tran et al., 2022) in developing countries where health care access is perceived as an opportunity and study attrition reported as low, regardless of ethical procedures around the voluntary nature of study participation and withdrawal. As a result, the attrition rate is expected to be very low for the intervention group too and therefore additional recruitment to account for attrition (15%) was not undertaken for the intervention group. Therefore, 64 dyads of parents and their children are required for the intervention group. The final sample size for the control group is 74 dyads, while the intervention group requires 64 dyads.



Reference
Nguyen, N. T., Douglas, C., & Bonner, A. (2019). Effectiveness of self-management programme in people with chronic kidney disease: A pragmatic randomized controlled trial. Journal of Advanced Nursing, 75(3), 652-664.

Staveski, S. L., Parveen, V. P., Madathil, S. B., Kools, S., & Franck, L. S. (2016). Parent education discharge instruction program for care of children at home after cardiac surgery in Southern India [Article]. Cardiology in the Young, 26(6), 1213-1220. https://doi.org/10.1017/S1047951115002462

Tran, D. M., Tran, T. T., Phung, T. T. B., Bui, H. T., Nguyen, P. T. T., Vu, T. T., Ngo, N. T. P., Nguyen, M. T., Nguyen, A. H., & Nguyen, A. T. V. (2022). Nasal-spraying Bacillus spores as an effective symptomatic treatment for children with acute respiratory syncytial virus infection. Scientific Reports, 12(1), 12402.

Zhang, Q.-L., Lei, Y.-Q., Liu, J.-F., Chen, Q., & Cao, H. (2022). Telehealth education improves parental care ability and postoperative nutritional status of infants after CHD surgery: A prospective randomized controlled study. Paediatrics & Child Health.



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
Completed
Date of first participant enrolment
Anticipated
26/06/2023
Actual
11/09/2023
Date of last participant enrolment
Anticipated
1/10/2023
Actual
24/11/2023
Date of last data collection
Anticipated
12/11/2023
Actual
31/03/2024
Sample size
Target
148
Accrual to date
Final
138
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
Approved
Ethics committee name [1] 312759 0
Queensland University of Technology Human Research Ethics Committee
Ethics committee address [1] 312759 0
Ethics committee country [1] 312759 0
Australia
Date submitted for ethics approval [1] 312759 0
30/03/2023
Approval date [1] 312759 0
13/07/2023
Ethics approval number [1] 312759 0
6724
Ethics committee name [2] 315743 0
Ethics Committee for Biomedical Research
Ethics committee address [2] 315743 0
Ethics committee country [2] 315743 0
Viet Nam
Date submitted for ethics approval [2] 315743 0
11/05/2023
Approval date [2] 315743 0
23/05/2023
Ethics approval number [2] 315743 0
VNCH-TRICH-2023-30

Summary
Brief summary
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
[email protected]
Contact person for public queries
Name 125807 0
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
[email protected]
Contact person for scientific queries
Name 125808 0
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
[email protected]

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.