The effectiveness of an evidence-based health education program for parents of children undergoing congenital heart disease (CHD) surgery in Vietnam: The main study.
- Conditions
- Congenital heart diseaseCardiovascular - Other cardiovascular diseasesSurgery - Other surgery
- Registration Number
- ACTRN12623000388617
- Lead Sponsor
- Queensland University of Technology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 138
Participants in this study (Phase 2), who are dyads of parents and their children, will be selected using the eligibility criteria as follows.
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.
Children who have complex chromosomal arrangements, other major comorbidities, or birth complications.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.[ Time point 1: At baseline by the principal researcher.<br>Time point 2: Hospital discharge by the research assistants.<br>Time point 3: Two weeks after discharge by the research assistants.<br>Time point 4: Six weeks after discharge by the research assistants..]
- Secondary Outcome Measures
Name Time Method Children's health outcomes will be assessed as a composite secondary outcome.<br><br>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. [ <br>Time point 1: At baseline by the principal researcher.<br>Time point 2: Hospital discharge by the research assistants.<br>Time point 3: Two weeks after discharge by the research assistants.<br>Time point 4: Six weeks after discharge by the research assistants.]