The Fontan Education Study: A Randomized Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Heart Defects, Congenital
• Intervention / Treatment: Other: Fontan Education Videos

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • Stollery Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Stress reactions in children and parents post Fontan. This video will be supplemented with existing resources on the topic.; Anticoagulation; Prolonged pleural drainage
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	child's PHBQ score 1 week and 1 month postoperatively	1 week and 1 month postoperatively

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Andrew S Mackie, MD, SM, University of Alberta

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: July 11, 2016
• First Submitted That Met QC Criteria: July 11, 2016
• First Posted (Estimate): July 13, 2016

Study Record Updates

• Last Update Posted (Actual): October 16, 2018
• Last Update Submitted That Met QC Criteria: October 12, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Heart Defects, Congenital
• Other Study ID Numbers: The Fontan Education Study