Back to resultsThe Fontan Education Study: A Randomized Control Trial
Primary Purpose
Heart Defects, Congenital
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Fontan Education Videos
Sponsored by
About this trial
This is an interventional other trial for Heart Defects, Congenital
Eligibility Criteria
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.
Sites / Locations
- Stollery Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Educational Intervention
Usual Care
Arm Description
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).
Participants in the usual care will not be offered an intervention and will not be made aware of the existence of the teaching videos.
Outcomes
Primary Outcome Measures
Parent's State Anxiety Inventory (STAI)-State score preoperatively
The primary endpoint is the parent's STAI-State score within 1 week preceding surgery.
Secondary Outcome Measures
STAI-State score postoperatively
Parent STAI-State score 1- week and 1-month postoperatively
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
child's PHBQ score 1 week and 1 month postoperatively
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02831790
Brief Title
The Fontan Education Study: A Randomized Control Trial
Official Title
The Fontan Education Study: A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Defects, Congenital
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Educational Intervention
Arm Type
Experimental
Arm Description
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).
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants in the usual care will not be offered an intervention and will not be made aware of the existence of the teaching videos.
Intervention Type
Other
Intervention Name(s)
Fontan Education Videos
Intervention Description
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:
Stress reactions in children and parents post Fontan. This video will be supplemented with existing resources on the topic.
Anticoagulation
Prolonged pleural drainage
Primary Outcome Measure Information:
Title
Parent's State Anxiety Inventory (STAI)-State score preoperatively
Description
The primary endpoint is the parent's STAI-State score within 1 week preceding surgery.
Time Frame
within 1 week preceding surgery
Secondary Outcome Measure Information:
Title
STAI-State score postoperatively
Description
Parent STAI-State score 1- week and 1-month postoperatively
Time Frame
1 week and 1 month postoperatively
Title
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
Description
child's PHBQ score 1 week and 1 month postoperatively
Time Frame
1 week and 1 month postoperatively
Other Pre-specified Outcome Measures:
Title
Semi-structured interviews postoperatively
Description
Semi-structured interviews will be conducted by a trained qualitative interviewer who works with a team member and has extensive experience with parents.
Time Frame
1 Month Postoperatively
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew S Mackie, MD, SM
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stollery Children's Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
The Fontan Education Study: A Randomized Control Trial
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