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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Educational Intervention | Experimental | Participants in the intervention group will have access to the 3 teaching videos, ~3:30-5:00 minutes in duration each, beginning several weeks prior to the preadmission clinic (as soon as written consent is obtained). |
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| Usual Care | No Intervention | Participants in the usual care will not be offered an intervention and will not be made aware of the existence of the teaching videos. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fontan Education Videos | Other | 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:
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| Measure | Description | Time Frame |
|---|---|---|
| Parent's State Anxiety Inventory (STAI)-State score preoperatively | The primary endpoint is the parent's STAI-State score within 1 week preceding surgery. | within 1 week preceding surgery |
| Measure | Description | Time Frame |
|---|---|---|
| STAI-State score postoperatively | Parent STAI-State score 1- week and 1-month postoperatively | 1 week and 1 month postoperatively |
| Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Semi-structured interviews postoperatively | Semi-structured interviews will be conducted by a trained qualitative interviewer who works with a team member and has extensive experience with parents. | 1 Month Postoperatively |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew S Mackie, MD, SM | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stollery Children's Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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child's PHBQ score 1 week and 1 month postoperatively
| 1 week and 1 month postoperatively |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |