Heart Defects, Congenital
Conditions
Brief summary
The Fontan Education Study is a cluster randomized controlled trial evaluating the impact of a novel education program in combination with usual care, versus usual care alone, on preparing parents of children undergoing Fontan surgery for the challenges of the postoperative course.
Interventions
OTHERFontan Education Videos
The intervention will consist of three brief (\ 5 minute) professionally-developed whiteboard videos, available online. The videos will feature lay language at a grade 7 level or below and will be engaging. Topics are based on key findings of the Family Resilience Study, namely: 1. Stress reactions in children and parents post Fontan. This video will be supplemented with existing resources on the topic. 2. Anticoagulation 3. Prolonged pleural drainage
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* children who are planned to undergo Fontan surgery within 4-6 weeks and their parent(s)/guardian(s)
Exclusion criteria
* parents with \< grade 6 level of English reading.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parent's State Anxiety Inventory (STAI)-State score preoperatively | within 1 week preceding surgery | The primary endpoint is the parent's STAI-State score within 1 week preceding surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| STAI-State score postoperatively | 1 week and 1 month postoperatively | Parent STAI-State score 1- week and 1-month postoperatively |
| Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively | 1 week and 1 month postoperatively | child's PHBQ score 1 week and 1 month postoperatively |
Other
| Measure | Time frame | Description |
|---|---|---|
| Semi-structured interviews postoperatively | 1 Month Postoperatively | Semi-structured interviews will be conducted by a trained qualitative interviewer who works with a team member and has extensive experience with parents. |
Countries
Canada
Outcome results
None listed