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The Fontan Education Study: A Randomized Control Trial

U

University of Alberta

Status

Completed

Conditions

Heart Defects, Congenital

Treatments

Other: Fontan Education Videos

Study type

Interventional

Funder types

Other

Identifiers

NCT02831790
The Fontan Education Study

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

26 participants in 2 patient groups

Educational Intervention
Experimental group
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).
Treatment:
Other: Fontan Education Videos
Usual Care
No Intervention group
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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