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

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital tool called Empower My Congenital Health (EmpowerMyCH), designed to help adults with congenital heart disease manage their health. The tool includes features like a digital medical passport, updated health information, and community support, all aimed at boosting users' confidence in managing their healthcare. The study aims to determine if participants find this tool useful and effective. It suits adults with congenital heart disease who can make their own healthcare decisions. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance self-management for many living with congenital heart disease.

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 prior data suggests that the Empower My Congenital Health (EmpowerMyCH) tool is safe?

Research has shown that digital health tools like Empower My Congenital Health (EmpowerMyCH) are generally safe. These tools educate and support individuals with congenital heart disease. One study found that patients used a similar digital platform without safety problems, suggesting that EmpowerMyCH should also be user-friendly and issue-free.

As a digital tool rather than a medication, EmpowerMyCH does not cause drug-related side effects. It provides information, community support, and resources to help manage heart health. Participants can feel confident in its safety, as it does not involve any physical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Empower My Congenital Health (EmpowerMyCH) tool because it introduces a digital approach to managing congenital heart disease. Unlike traditional treatments that often focus solely on medical procedures or medications, this tool provides a comprehensive, web and mobile-based platform that empowers patients through a digital medical passport, timely health updates, and access to credible resources. It also fosters a sense of community by connecting users with peers and experts for support and guidance. This holistic approach aims to enhance patient engagement and self-management, potentially leading to better health outcomes.

What evidence suggests that the Empower My Congenital Health tool is effective for congenital heart disease?

Research has shown that digital health tools can help patients manage their health effectively. This trial specifically tests Empower My Congenital Health (EmpowerMyCH) for individuals with congenital heart disease. Studies have found that digital tools can boost patient confidence and involvement in their healthcare. EmpowerMyCH provides features such as a digital medical passport and community support to simplify and enhance health management. With over 97% of congenital heart disease patients now reaching adulthood, tools like this are crucial for long-term health management. Early results suggest that these digital tools can lead to better health outcomes. ^{2 6 7 8 9}

Who Is on the Research Team?

Anushree Agarwal, MBBS, MAS

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06581484

Improving Congenital Heart Disease Care (EmpowerMyCH) Study Overview. The theory-informed digital health intervention, called as "Empower My Congenital Health (EmpowerMyCH)" aims to activate and engage ACHD ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11581669/

Patient-Reported Outcomes Among Adults With Congenital ... Of the patients who reported a mood disorder, 24% (318 patients) had normal scores per their HADS reporting, indicating good symptom control.

3. cambridge.org cambridge.org/core/journals/cardiology-in-the-young/article/empowering-patients-with-congenital-heart-disease-development-of-a-digital-question-prompt-list-for-shared-decisionmaking-a-pilot-study/1997BD1F48817FA44F67BC48960F423C

Empowering Patients with Congenital Heart Disease ... Background: Advancements in healthcare have significantly improved the prospect of patients with CHD, with over 97% now surviving adulthood.

4. clinicaltrials.ucbraid.org clinicaltrials.ucbraid.org/congenital-heart-defect

University of California Health Congenital Heart Defects ... The purpose of this initiative is to improve care and outcomes for infants with HLHS by expanding the NPC-QIC national registry to gather ...

5. medrxiv.org medrxiv.org/content/10.1101/2025.03.31.25324723v1.full.pdf

Theory-based and Person-centered Approach to Design a ... We, therefore, developed a browser and mobile app-based tool called “Empower My Congenital Heart (EmpowerMyCH)” to enhance the uptake of a.

6. empowermych.org empowermych.org/

Join Empower My Congenital Heart | Confident Healthcare ... EmpowerMyCH allows patients to find reliable information that can improve their understanding of their congenital heart disease. Jennifer Gilmartin, NP ACHD ...

7. aap.org aap.org/en/patient-care/congenital-heart-defects/congenital-heart-public-health-consortium/access-to-care-for-congenital-heart-disease/?srsltid=AfmBOop0xr6IGCibQyoW0XHTMcR40tnPzA1RYU2momqRGagg0B284uVo

Access to Care for Congenital Heart Disease Congenital heart defects represent the most common birth defect in the United States (US), af fecting 1 in 100 children born.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167527322006532

Patient monitoring and education over a tailored digital ... Patient monitoring and education over a tailored digital application platform for congenital heart disease: A feasibility pilot study. Author ...

9. ahajournals.org ahajournals.org/doi/full/10.1161/CIRCRESAHA.124.325596?doi=10.1161/CIRCRESAHA.124.325596

Lifelong Care of Females With Congenital Heart Disease As many as two-thirds of females report using no or less effective contraception with a high failure rate (barrier, withdrawal, fertility ...