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The Impact of an Innovative eHealth Transition Intervention on Self-Management Skills Among Young Adults With Congenital Heart Disease (READYorNot CHD)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04463446
Recruitment Status : Not yet recruiting
First Posted : July 9, 2020
Last Update Posted : July 22, 2020
Sponsor:
Collaborators:
McGill University
Oregon Health and Science University
University of British Columbia
University of Toronto
Université de Montréal
Information provided by (Responsible Party):
University of Alberta

Brief Summary:

Congenital heart disease (CHD) survivors constitute one of the fastest growing populations in adult cardiology practices. This population is vulnerable to gaps in care, particularly as they graduate from the pediatric to adult healthcare system. Their healthcare needs are complex, and preparing this population for transfer to adult care is a resource-intense process.

This trial will evaluate the use of the MyREADY Transition CHD app against a nurse-led one-time intervention in clinic. Participants will be 16-17 year olds who attend a cardiology outpatient clinic. The app will allow young adults to learn about their heart condition and about self-management skills in the context of adult healthcare by using the app for 18 months. The nurse-led intervention will cover similar topics, but in a one-time in-person session with a clinic nurse.

Outcomes: The primary outcome is change in Transition Readiness Assessment Questionnaire (TRAQ) score over time. Secondary outcomes are change in the MyHeart Score and the General Self-Efficacy (GSE) score. These questionnaires will be answered by all participants at regular intervals (enrollment, 1 month, 6 months, 12 months, 18 months) throughout the trial. The trial will also consider time to the first adult cardiology appointment, cost of the interventions, and will conduct interviews with participants in the app group to learn about their experiences using the app.


Condition or disease Intervention/treatment Phase
Congenital Heart Disease Congenital Heart Disease in Adolescence Behavioral: Use of the CHD app Behavioral: Nurse-led intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Impact of an Innovative eHealth Transition Intervention on Self-Management Skills Among Young Adults With Congenital Heart Disease
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
Experimental: The app arm
Use of CHD app
Behavioral: Use of the CHD app
Use of the CHD app

Active Comparator: Nurse-led intervention arm
Nurse-led intervention
Behavioral: Nurse-led intervention
Teaching session with clinic nurse




Primary Outcome Measures :
  1. Transition Readiness Assessment Questionnaire [ Time Frame: 18 months ]

    The Transition Readiness Assessment Questionnaire contains a series of questions in which the youth is asked to describe their ability level in various skill areas related to their health and health care, using the following scale:

    No, I do not know how No, but I want to learn No, but I am learning to do this Yes, I have started doing this Yes, I always do this when I need to

    This produces a minimum score 20, max score 100. A higher score indicates a better outcome.



Secondary Outcome Measures :
  1. MyHeart Score [ Time Frame: 18 months ]
    The MyHeart Scale assess CHD knowledge. Score is 0-100, a higher score indicates a better outcome.

  2. General Self-Efficacy Score [ Time Frame: 18 months ]
    The scale was created to assess a general sense of perceived self-efficacy with the aim in mind to predict coping with daily hassles as well as adaptation after experiencing all kinds of stressful life events. Score is between 10-40, a higher score insicates a better outcome.


Other Outcome Measures:
  1. Excess time to adult care [ Time Frame: 18 months ]
    The recommended time to first adult cardiology appointment will be compared to the actual time to first adult cardiology appointment. Participants who have not attended the adult clinic by the end of the study period (i.e., are "censored") will still contribute to this outcome as survival analysis is designed to accommodate censored data. Delays in attending the adult clinic related to system factors (e.g. waiting list) will be documented.



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:   16 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • moderate or complex CHD
  • seen at outpatient cardiology clinic at participating pediatric hospital

Exclusion Criteria:

  • < Grade 6 level of reading and comprehension
  • heart transplantation

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): NCT04463446


Contacts
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Contact: Andrew Mackie 780-407-8361 andrew.mackie@ahs.ca
Contact: Daniella San Martin-Feeney 780-407-3794 daniella.sanmartin-feeney@ahs.ca

Sponsors and Collaborators
University of Alberta
McGill University
Oregon Health and Science University
University of British Columbia
University of Toronto
Université de Montréal
Investigators
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Principal Investigator: Andrew Mackie University of Alberta
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT04463446    
Other Study ID Numbers: Pro00097233
First Posted: July 9, 2020    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities