The Fontan Education Study: A Randomized Control Trial

Not Applicable

Completed

• Conditions: Heart Defects, Congenital
• Interventions: Other: Fontan Education Videos

• Registration Number: NCT02831790
• Lead Sponsor: University of Alberta

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-11
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-13
• Status Verified: 2018-05
• Primary Completion: 2018-07
• Study Completion: 2018-08
• Last Update Submitted: 2018-10-12
• Last Update Posted: 2018-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• children who are planned to undergo Fontan surgery within 4-6 weeks and their parent(s)/guardian(s)

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Exclusion Criteria

• parents with < grade 6 level of English reading.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Educational Intervention	Fontan Education Videos	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).

Primary Outcome Measures

Name	Time	Method
Parent's State Anxiety Inventory (STAI)-State score preoperatively	within 1 week preceding surgery	The primary endpoint is the parent's STAI-State score within 1 week preceding surgery.

Secondary Outcome Measures

Name	Time	Method
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively	1 week and 1 month postoperatively	child's PHBQ score 1 week and 1 month postoperatively
STAI-State score postoperatively	1 week and 1 month postoperatively	Parent STAI-State score 1- week and 1-month postoperatively

Trial Locations

Locations (1)

Stollery Children's Hospital; 🇨🇦 Edmonton, Alberta, Canada