NCT06581484 · University of California, San Francisco
Improving Congenital Heart Disease Care
(EmpowerMyCH)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Digital patient empowerment intervention
The intervention has features such as a digital medical passport, updated health-related information, community support and patient/peer stories and advice
Primary outcome measures
Recruitment rate
Time frame: 6-12 months
Number of patients recruited out of all the eligible patient approached for recruitment
Satisfaction with the intervention components
Time frame: 0, 6 and 12 months
Scores on client satisfaction questionnaire (CSQ-8) survey. Scores are summed across items once. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Acceptability of the intervention components
Time frame: 0, 6 and 12 months
Rates of app downloads. The investigators will download app data monthly to evaluate the frequency and duration of the use of various intervention components. The investigators will recruit 10 participants for focused group discussions on acceptability of the app.
Feasibility of the intervention
Time frame: 0, 6 and 12 months
Ability to download the app or any technical difficulties with the app or its features.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- have congenital heart disease
- 18 years or older
- can sign the informed consent
Exclusion criteria
- developmentally delayed
- unable to consent
Where
- San Francisco, California
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 23, 2026 · Source of record for eligibility and locations