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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment MyREADY Transition CHD app and Nurse-led intervention for congenital heart disease?

Research suggests that mobile health apps can improve care quality and communication between patients and providers, although regular use can be challenging. Additionally, eHealth interventions have shown potential in encouraging physical activity and improving health-related quality of life in adolescents with congenital heart disease. ^{1 2 3 4 5}

Is the eHealth app or nurse-led intervention safe for humans?

The studies suggest that using mobile health apps and nurse-led interventions for congenital heart disease is generally safe, with no specific safety concerns reported. However, compliance with app use can be challenging, and inappropriate use may lead to data overload. ^{1 2 3 5 6}

How is the MyREADY Transition CHD app and nurse-led intervention treatment different from other treatments for congenital heart disease?

The MyREADY Transition CHD app and nurse-led intervention is unique because it combines a mobile health app with personalized nurse support to help young adults transition from pediatric to adult cardiology care, focusing on improving self-care skills and patient-provider communication, which is not typically addressed by standard treatments. ^{1 2 3 5 7}

Research Team

Andrew Mackie, MD

Principal Investigator

University of Alberta

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Use of a disease-specific mobile health application in the care of adults with congenital heart disease. [2020]

2. Canada pubmed.ncbi.nlm.nih.gov

Texting teens in transition: the use of text messages in clinical intervention research. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of eHealth physical activity encouragement in adolescents with complex congenital heart disease: The PReVaiL randomized clinical trial. [2017]

4. United States 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. [2017]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Adults with congenital heart disease: ready for mobile health? [2020]

6. Netherlands pubmed.ncbi.nlm.nih.gov

First real-world experience with mobile health telemonitoring in adult patients with congenital heart disease. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Transition to adult care of young people with congenital heart disease: impact of a service on knowledge and self-care skills and correlates of a successful transition. [2023]