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Completed

NCT Number: NCT02831790

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.

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Key information

Conditions

Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fontan Education Videos

Other

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 outcomes

  1. Parent's State Anxiety Inventory (STAI)-State score preoperatively

    Time frame: within 1 week preceding surgery

    The primary endpoint is the parent's STAI-State score within 1 week preceding surgery.

Secondary outcomes

  1. STAI-State score postoperatively

    Time frame: 1 week and 1 month postoperatively

    Parent STAI-State score 1- week and 1-month postoperatively

  2. Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively

    Time frame: 1 week and 1 month postoperatively

    child's PHBQ score 1 week and 1 month postoperatively

Other outcomes

  1. Semi-structured interviews postoperatively

    Time frame: 1 Month Postoperatively

    Semi-structured interviews will be conducted by a trained qualitative interviewer who works with a team member and has extensive experience with parents.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 13, 2016
Registry last updated
Oct 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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