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Trial registered on ANZCTR


Registration number
ACTRN12623000384651
Ethics application status
Approved
Date submitted
29/03/2023
Date registered
17/04/2023
Date last updated
25/04/2024
Date data sharing statement initially provided
17/04/2023
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: A pilot study.
Scientific title
A two-group quasi-experimental pilot 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 1).
Secondary ID [1] 308977 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congenital heart disease 329030 0
Condition category
Condition code
Cardiovascular 326012 326012 0 0
Other cardiovascular diseases
Surgery 326537 326537 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] 325440 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] 333867 0
Parent acceptability of the evidence-based health education program, which is parents' perspectives about the intervention, will be measured using the Parental Perception on the Feasibility Instrument. The instrument was developed by the principal researcher for the study purpose. Only intervention group parents will self-rate their perspectives using the instrument.
Timepoint [1] 333867 0
Time point 1: Hospital discharge.
Time point 2: Six weeks after discharge.
Primary outcome [2] 334306 0
The feasibility of the study protocol will be captured by the principal researcher. All the feasibility measures will be assessed as a composite primary outcome, including:

Eligibility rate will be determined by an audit of the study screening and consent log.

Parent consent rate will be determined by an audit of the study screening and consent log.

Parent participation rate will be calculated based on the training session attendance list.

Missing data will be evaluated by an audit of the study dataset with a focus on the missing values.

Lost-to-follow-up will be determined by a review of the study measurement attendance list.

Sufficiency of a two-week wash-out period will be assessed by monitoring the number of control group parents who are still in the ward when the intervention group parents arrive in to define appropriate time for Phase 2.
Timepoint [2] 334306 0
During screening and consent processes: Eligibility rate and parent consent.
Daily monitoring: Parent participation rate, missing data and lost-to-follow-up.
Two weeks after the anticipated discharge date of the last control group dyads: sufficiency of a two-week wash-out period.
Secondary outcome [1] 418577 0
Parental CHD knowledge will be assessed 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 principal researcher will read questions to parents and note their responses.
Timepoint [1] 418577 0
Time point 1: At baseline
Time point 2: Hospital discharge
Time point 3: Two weeks after discharge
Time point 4: Six weeks after discharge.
Secondary outcome [2] 420203 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. The principal researcher will collect children's health outcomes in this phase.
Timepoint [2] 420203 0
Time point 1: At baseline.
Time point 2: Hospital discharge.
Time point 3: Two weeks after discharge.
Time point 4: Six weeks after discharge.

Eligibility
Key inclusion criteria
Participants in this pilot study (Phase 1), 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 and 11 moths 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.

In this pilot study (Phase 1), ten control group dyads will be recruited first, which is forecasted to complete in a week. Following that, a two-week wash-out period be spent prior to recruiting 10 intervention group dyads.
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 1 pilot 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
Phase 1 pilot study will employ a convenience sample of 10 dyads of parents and children for each group, namely the intervention and control groups.

Statistical methods

* The feasibility of the study protocol will be calculated as follows.

Eligibility rate: divide numbers of eligible dyads of parents and children by total screened participants and then multiplied by 100.
The parent consent rate: a sum of parents who agree to join the program divided by total eligible parents and then multiplied by 100.
The parent participation rate in the evidence-based health education program: counting active parents who participate in each training session, divided by number of intervention group parents and multiplied by 100.
Missing data rate: the percentage of missing data value in the observation of interest in each time point of measurement.
Lost-to-follow-up rate: dividing numbers of parents who do not complete the study instruments by total intervention group parents and then multiplied by 100.
Sufficiency in the wash-out period: counting the number of control group parents still in ward when intervention group parents arrive in to consider the sufficient time for Phase 2.

*Other outcomes, for example parental CHD knowledge and children's health outcomes.

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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2023
Actual
1/08/2023
Date of last participant enrolment
Anticipated
28/05/2023
Actual
23/08/2023
Date of last data collection
Anticipated
9/07/2023
Actual
30/12/2023
Sample size
Target
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 25266 0
Viet Nam
State/province [1] 25266 0
Hanoi

Funding & Sponsors
Funding source category [1] 313193 0
University
Name [1] 313193 0
Queensland University of Technology Research Award (QUTPRA (International) and QUT HDR Tuition Fee Sponsorship
Country [1] 313193 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] 315285 0
Hospital
Name [1] 315285 0
Vietnam National Children's Hospital
Address [1] 315285 0
18/879 La Thanh, Dong Da, Hanoi, Vietnam
Country [1] 315285 0
Viet Nam

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312425 0
Queensland University of Technology Human Research Ethics Committee
Ethics committee address [1] 312425 0
Office of Research Ethics and Integrity: Human research ethics
Level 4, X block, Kelvin Grove
Brisbane, QLD 4059
Ethics committee country [1] 312425 0
Australia
Date submitted for ethics approval [1] 312425 0
30/03/2023
Approval date [1] 312425 0
13/07/2023
Ethics approval number [1] 312425 0
Ethics committee name [2] 315193 0
Ethics Committee for Biomedical Research
Ethics committee address [2] 315193 0
Vietnam National Children's Hospital
18/879 La Thanh, Dong Da, Hanoi, Vietnam
Tel: +84 24 6273 8648
Website: rich.org.vn
Ethics committee country [2] 315193 0
Viet Nam
Date submitted for ethics approval [2] 315193 0
11/05/2023
Approval date [2] 315193 0
23/05/2023
Ethics approval number [2] 315193 0
VNCH-TRICH-2023-30

Summary
Brief summary
This study aims to evaluate the feasibility of the evidence-based health education program for parents of children undergoing CHD surgery and the feasibility of the study protocol to conduct a larger trial in Phase 2.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124618 0
Mrs Tran Thi Mai Huong
Address 124618 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 124618 0
Australia
Phone 124618 0
+61 731388621
Fax 124618 0
Email 124618 0
[email protected]
Contact person for public queries
Name 124619 0
Tran Thi Mai Huong
Address 124619 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 124619 0
Australia
Phone 124619 0
+61 731388621
Fax 124619 0
Email 124619 0
[email protected]
Contact person for scientific queries
Name 124620 0
Tran Thi Mai Huong
Address 124620 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 124620 0
Australia
Phone 124620 0
+61 731388621
Fax 124620 0
Email 124620 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.