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The Fontan Education Study: A Randomized Control Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02831790
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Heart Defects, Congenital Other: Fontan Education Videos Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: The Fontan Education Study: A Randomized Control Trial
Study Start Date : July 2016
Actual Primary Completion Date : July 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


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:

  1. Stress reactions in children and parents post Fontan. This video will be supplemented with existing resources on the topic.
  2. Anticoagulation
  3. 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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831790


Locations
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Canada, Alberta
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Andrew S Mackie, MD, SM University of Alberta

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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT02831790    
Other Study ID Numbers: The Fontan Education Study
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Heart Defects, Congenital
Congenital Abnormalities
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases