The Fontan Education Study: A Randomized Control Trial
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 11, 2016
CompletedFirst Posted
Study publicly available on registry
July 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedOctober 16, 2018
May 1, 2018
2 years
July 11, 2016
October 12, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
STAI-State score postoperatively
1 week and 1 month postoperatively
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
1 week and 1 month postoperatively
Other Outcomes (1)
Semi-structured interviews postoperatively
1 Month Postoperatively
Study Arms (2)
Educational Intervention
EXPERIMENTALParticipants 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).
Usual Care
NO INTERVENTIONParticipants in the usual care will not be offered an intervention and will not be made aware of the existence of the teaching videos.
Interventions
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
Eligibility Criteria
You may qualify if:
- children who are planned to undergo Fontan surgery within 4-6 weeks and their parent(s)/guardian(s)
You may not qualify if:
- parents with \< grade 6 level of English reading.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew S Mackie, MD, SM
University of Alberta
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2016
First Posted
July 13, 2016
Study Start
July 1, 2016
Primary Completion
July 1, 2018
Study Completion
August 1, 2018
Last Updated
October 16, 2018
Record last verified: 2018-05