Digital Health Tool for Congenital Heart Disease

(EmpowerMyCH Trial)

Overseen By Anushree Agarwal, MBBS, MAS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Developmentally delayed, unable to consent

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

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Empower My Congenital Health (EmpowerMyCH)?

Research on similar digital health tools, like the MyHeartApp, suggests they can improve care quality and communication between patients and providers for congenital heart disease, although regular use can be challenging. ^{1 2 3 4 5}

Is the Digital Health Tool for Congenital Heart Disease safe for humans?

The pilot study of the MyHeartApp, a mobile application for adults with congenital heart disease, found it to be potentially helpful and easy to use, with no specific safety concerns reported. However, the study focused on its utility and compliance rather than detailed safety data. ^{1 2 5 6 7}

How is the EmpowerMyCH treatment different from other treatments for congenital heart disease?

EmpowerMyCH is unique because it uses a digital health tool, likely a mobile app, to improve care quality and communication between patients and providers for congenital heart disease. This approach is different from traditional treatments as it focuses on enhancing patient engagement and compliance through technology. ^{1 2 8 9 10}

What is the purpose of this trial?

The theory-informed digital health intervention, called as "Empower My Congenital Health (EmpowerMyCH)" aims to activate and engage ACHD patients in building confidence toward navigating the adult healthcare system. This tool is built after incorporating the theories of behavior change, gathering inputs from target patients in all stages of its design and implementation. The key features of the tool include a digital medical passport, updated congenital information, community support, and patient stories and advice. The investigators aim to test the acceptability, feasibility, efficacy, and effectiveness of the intervention.

Research Team

Anushree Agarwal, MBBS, MAS

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for adults with congenital heart disease (CHD) who are interested in using a digital tool to help manage their condition. The tool aims to empower patients by providing resources and community support.

Inclusion Criteria

I was born with a heart condition.

I can understand and sign the consent form.

Exclusion Criteria

I am unable to give consent by myself.

Developmentally delayed

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage with the digital multi-component intervention to enhance patient engagement skills and lead to timely specialist visits

12 months

Regular intervals via web or mobile

Follow-up

Participants are monitored for the effectiveness of the intervention and timely specialist visits

12 months

Long-term Follow-up

Participants' quality of life and empowerment levels are assessed over an extended period

24-36 months

Treatment Details

Interventions

• Empower My Congenital Health (EmpowerMyCH)

Trial Overview The 'Empower My Congenital Health' digital intervention is being tested for its ability to help CHD patients navigate the healthcare system, increase confidence, and improve health behaviors through features like a medical passport and patient stories.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

This is a digital (web and mobile-based) multicomponent patient engagement behavioral intervention. The intervention components include digital medical passport, health-specific updated information, credible resources, connections with the community, peer- and expert support and guidance, among others

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

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. 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]

3. 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]

4. England pubmed.ncbi.nlm.nih.gov

Evaluation of a new digital pediatric malnutrition risk screening tool for hospitalized children with congenital heart disease. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Examining the Real-Life Journey of Individuals and Families Affected by Single-Ventricle Congenital Heart Disease. [2023]

6. England pubmed.ncbi.nlm.nih.gov

The nomenclature of safety and quality of care for patients with congenital cardiac disease: a report of the Society of Thoracic Surgeons Congenital Database Taskforce Subcommittee on Patient Safety. [2021]

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

Clinical Databases and Registries in Congenital and Pediatric Cardiac Surgery, Cardiology, Critical Care, and Anesthesiology Worldwide. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Involving patients, families and medical staff in the evaluation of 3D printing models of congenital heart disease. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Development and validation of a risk prediction model in patients with adult congenital heart disease. [2019]

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

The Use of Virtual Reality Learning on Transition Education in Adolescents with Congenital Heart Disease. [2023]