The Impact of an Innovative eHealth Transition Intervention on Self-Management Skills Among Young Adults With Congenital Heart Disease (READYorNot CHD)
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|ClinicalTrials.gov Identifier: NCT04463446|
Recruitment Status : Not yet recruiting
First Posted : July 9, 2020
Last Update Posted : July 22, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||188 participants|
|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|
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
Behavioral: Nurse-led intervention
Teaching session with clinic nurse
- 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.
- MyHeart Score [ Time Frame: 18 months ]The MyHeart Scale assess CHD knowledge. Score is 0-100, a higher score indicates a better outcome.
- 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.
- 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.
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
|Contact: Andrew Mackiefirstname.lastname@example.org|
|Contact: Daniella San Martin-Feeneyemail@example.com|
|Principal Investigator:||Andrew Mackie||University of Alberta|