NCT04463446

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
1.5 years until next milestone

Study Start

First participant enrolled

January 10, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

4 years

First QC Date

July 3, 2020

Last Update Submit

March 11, 2026

Conditions

Congenital Heart DiseaseCongenital Heart Disease in Adolescence

Outcome Measures

Primary Outcomes (1)

  • Transition Readiness Assessment Questionnaire

    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.

    18 months

Secondary Outcomes (2)

  • MyHeart Score

    18 months

  • General Self-Efficacy Score

    18 months

Other Outcomes (1)

  • Excess time to adult care

    18 months

Study Arms (2)

The app arm

EXPERIMENTAL

Use of CHD app

Behavioral: Use of the CHD app

Nurse-led intervention arm

ACTIVE COMPARATOR

Nurse-led intervention

Behavioral: Nurse-led intervention

Interventions

Nurse-led interventionBEHAVIORAL

Teaching session with clinic nurse

Nurse-led intervention arm
Use of the CHD appBEHAVIORAL

Use of the CHD app

The app arm

Eligibility Criteria

Age16 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (1)

  • Mackie AS, Kovacs AH, San Martin-Feeney D, Via-Dufresne Ley A, McCrindle BW, Harris KC, Fournier A, Chappell A, Gingrich J, Dimitropoulos G, Allemang B, Gill N, Aiello S, Rolland M, O'Shea S, Legge L, Collins JA, Casey S, Breault F, Provencher F, Balmir R, Gutierrez Rojas R, Yaskina M, Klarenbach S, Zwicker J, Brophy JM, Woodgate RL, Marelli AJ. A Cluster Randomized Trial of an mHealth Intervention for Adolescents With Congenital Heart Disease: Rationale and Design of the READYorNot CHD Study. CJC Pediatr Congenit Heart Dis. 2025 Jun 7;5(1):1-11. doi: 10.1016/j.cjcpc.2025.06.001. eCollection 2026 Feb.

    PMID: 41767027DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Andrew Mackie

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2020

First Posted

July 9, 2020

Study Start

January 10, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

March 13, 2026

Record last verified: 2026-03

Locations

CA(1)