eHealth App vs Nurse-Led Intervention for Congenital Heart Disease

(READYorNot CHD Trial)

Overseen By Andrew Mackie

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Heart transplantation, < Grade 6 reading

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 60

207 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help teens with congenital heart disease (CHD) transition smoothly from pediatric to adult healthcare. Researchers are comparing two methods: an eHealth app called MyREADY Transition CHD and a one-time nurse-led session. The app teaches self-management skills over 18 months, while the nurse session covers similar topics in one meeting. Teens aged 16-17 with moderate or complex CHD who attend a participating cardiology clinic might be a good fit. The trial will assess how prepared participants feel for adult care and the effectiveness of each method in helping them manage their condition. This unphased trial offers a unique opportunity for participants to contribute to research that could improve transition care for future teens with CHD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using an app or attending a nurse-led session to help manage your heart condition.

What prior data suggests that these interventions are safe for adolescents with congenital heart disease?

Research has shown that the MyREADY Transition CHD app is generally safe for young adults with congenital heart disease (CHD). The app educates and empowers teens to manage their health as they transition to adult care. Without involving medication or physical treatment, it poses no drug-related side effects or risks. Instead, it serves as a digital tool to help users learn about their condition and develop self-management skills.

Similarly, the nurse-led intervention in this study is a safe method. It includes a one-time, in-person session with a nurse to discuss the same topics as the app. With no medication or invasive procedures involved, safety concerns remain minimal. Both the app and the nurse-led intervention aim to help CHD patients understand and manage their health effectively, without risking their physical well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for congenital heart disease (CHD) because they explore innovative ways to support patients transitioning from pediatric to adult care. The MyREADY Transition CHD app is unique because it leverages digital technology to provide personalized health management and education, potentially increasing patient engagement and adherence to care plans. On the other hand, the nurse-led intervention offers a personalized, human touch, with healthcare professionals providing tailored advice and support. Both approaches aim to improve patient outcomes by enhancing self-management and ensuring a smoother transition to adult care, which is a critical period for individuals with CHD.

What evidence suggests that this trial's treatments could be effective for congenital heart disease?

This trial will compare the effectiveness of the MyREADY Transition CHD app with a nurse-led intervention for young people with congenital heart disease (CHD) transitioning to adult care. Research has shown that digital tools can assist in managing health during this transition. Although specific data on the MyREADY Transition CHD app's effectiveness is not yet available, digital programs like it are designed to teach essential self-care skills. The app provides ongoing support and information about heart conditions, helping users feel more prepared for adult healthcare. Unlike a one-time session, the app offers continuous learning and support. While hard data is still forthcoming, the app's ongoing engagement may serve as a valuable resource for young adults moving to adult care. ^{2 6 7 8 9}

Who Is on the Research Team?

Andrew Mackie, MD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for young adults aged 16-17 with moderate or complex congenital heart disease (CHD) who are patients at a participating pediatric cardiology outpatient clinic. It's not suitable for those with a reading and comprehension level below Grade 6 or who have had a heart transplant.

Inclusion Criteria

Seen at outpatient cardiology clinic at participating pediatric hospital

I have moderate or complex congenital heart disease.

Exclusion Criteria

I have had a heart transplant.

Below Grade 6 level of reading and comprehension

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either the MyREADY Transition CHD app or a nurse-led one-time intervention in clinic

18 months

Monthly app reminders and quarterly check-ins for app group; one-time 60-75 minute session for nurse-led group

Follow-up

Participants complete questionnaires at enrollment, 1, 6, 12, and 18 months post enrollment to assess outcomes

18 months

Questionnaires completed at home or arranged access

What Are the Treatments Tested in This Trial?

Interventions

• MyREADY Transition CHD app
• Nurse-led intervention

Trial Overview The study compares two methods to help CHD patients transition from pediatric to adult healthcare: an innovative MyREADY Transition CHD app, which they'll use over 18 months, versus a one-time nurse-led session covering self-management skills.

How Is the Trial Designed?

Group I: The app arm Experimental Treatment 1 Intervention

Use of CHD app

Group II: Nurse-led intervention arm Active Control 1 Intervention

Nurse-led intervention

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Université de Montréal

Collaborator

Trials

223

Recruited

104,000+

McGill University

Collaborator

Trials

421

Recruited

1,017,000+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

University of Toronto

Collaborator

Trials

739

Recruited

1,125,000+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

Published Research Related to This Trial

This study involves 216 adolescents aged 13-16 with surgically corrected congenital heart disease, testing the impact of a year-long e-Health intervention on their physical fitness and quality of life.

The intervention includes weekly tailored encouragements via SMS and mobile apps, aiming to enhance physical activity, with the hypothesis that it will improve fitness levels measured by maximal oxygen uptake (Vo2) after 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and rationale for the PREVAIL study: effect of e-Health individually tailored encouragements to physical exercise on aerobic fitness among adolescents with congenital heart disease--a randomized clinical trial. Klausen, SH., Mikkelsen, UR., Hirth, A., et al.[2017]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2772812925000764

A Cluster Randomized Trial of an mHealth Intervention for ... However, there are no outcome data on the impact and effectiveness of CHD transition applications. Accordingly, in partnership with a Youth ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04463446

Study Details | NCT04463446 | The Impact of an Innovative ... 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 ...

3. researchsquare.com researchsquare.com/article/rs-6949970/v1.pdf?c=1753973853000

Digital interventions for facilitating the transition of young ... One ongoing RCT is examining the. MyREADY Transition CHD app to determine its effectiveness in enhancing self-management compared to nurse ...

4. researchgate.net researchgate.net/publication/392500544_A_cluster_randomized_trial_of_an_mHealth_intervention_for_adolescents_with_congenital_heart_disease_Rationale_and_design_of_the_READYorNotTM_CHD_Study

A Cluster Randomized Trial of an mHealth Intervention for ... One ongoing RCT is examining the MyREADY Transition CHD app to determine its effectiveness in enhancing self-management compared to nurse-led interventions (43) ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38864791/

Efficacy of a Transition Program in Adolescents and Young ... Purpose: Currently, nearly 90% of patients with congenital heart disease (CHD) reach adulthood in relatively good health. Structured transition ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04463446/the-impact-of-an-innovative-ehealth-transition-intervention-on-self-management-skills-among-young-adults-with-congenital-heart-disease

The Impact of an Innovative eHealth Transition Intervention ... 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- ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6298756/

Mobile App Development Using Formative Research - PMC Congenital heart diseases (CHDs) are the most common type of birth defects. Improvements in CHD care have led to approximately 1.4 million survivors ...

8. play.google.com play.google.com/store/apps/details?id=com.rootquotient.mcgill.childbright.preprod&hl=en_US

MyREADY Transition CHD App The MyREADY Transition CHD App for adolescents with Congenital Heart Disease (CHD) is designed to educate and empower youth as they prepare for transition.

9. acc.org acc.org/latest-in-cardiology/articles/2020/05/20/08/44/transitioning-the-adolescent-with-congenital-heart-disease

Transitioning the Adolescent with Congenital Heart Disease They found that only 39% of patients successfully transferred from pediatric to adult services during the study period. However, those with ...