The Fontan Education Study: A Randomized Control Trial
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|ClinicalTrials.gov Identifier: NCT02831790|
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : October 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Heart Defects, Congenital||Other: Fontan Education Videos||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Fontan Education Study: A Randomized Control Trial|
|Study Start Date :||July 2016|
|Actual Primary Completion Date :||July 2018|
|Actual Study Completion Date :||August 2018|
Experimental: Educational Intervention
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).
Other: Fontan 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:
No Intervention: Usual Care
Participants in the usual care will not be offered an intervention and will not be made aware of the existence of the teaching videos.
- Parent's State Anxiety Inventory (STAI)-State score preoperatively [ Time Frame: within 1 week preceding surgery ]The primary endpoint is the parent's STAI-State score within 1 week preceding surgery.
- STAI-State score postoperatively [ Time Frame: 1 week and 1 month postoperatively ]Parent STAI-State score 1- week and 1-month postoperatively
- Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively [ Time Frame: 1 week and 1 month postoperatively ]child's PHBQ score 1 week and 1 month postoperatively
- Semi-structured interviews postoperatively [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831790
|Stollery Children's Hospital|
|Edmonton, Alberta, Canada, T6G 2B7|
|Principal Investigator:||Andrew S Mackie, MD, SM||University of Alberta|