The Fontan Education Study: A Randomized Control Trial

Heart Defects, Congenital Clinical Trial

Official title:

The Fontan Education Study: A Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02831790
• Other study ID #: The Fontan Education Study
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: August 2018

Study information

• Verified date: May 2018
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital

Intervention

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

Locations

Country	Name	City	State
Canada	Stollery Children's Hospital	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	STAI-State score postoperatively	Parent STAI-State score 1- week and 1-month postoperatively	1 week and 1 month postoperatively
Secondary	Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively	child's PHBQ score 1 week and 1 month postoperatively	1 week and 1 month postoperatively