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Behavioral Intervention

Digital Health Tool for Congenital Heart Disease (EmpowerMyCH Trial)

N/A

Waitlist Available

Led By Anushree Agarwal, MBBS, MAS

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with congenital heart disease

Aged 18 years or older

Must not have

Unable to consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 6, 12, and 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a digital health tool called "Empower My Congenital Health" designed to help adults with congenital heart disease navigate the healthcare system with confidence. The tool includes features like

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is a digital empowerment tool, traditional physical side effects are not applicable. However, users may experience increased screen time or stress if technical issues arise.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I was born with a heart condition.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am unable to give consent by myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 6, 12, and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 6, 12, and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 6, 12, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of the intervention components

Feasibility of the intervention

Recruitment rate

+1 more

Secondary study objectives

Euro-Quality of Life

Gothenburg Empowerment Scale (GES)

Patient activation measure (PAM)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment1 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

0 / 3Eligibility criteria met