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NCT Number: NCT06581484

Improving Congenital Heart Disease Care

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.

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Key information

Conditions

Congenital Heart Disease Activation, Patient Behavior Behavior, Health Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Empowerment, Patient Health Behavior Heart Defects, Congenital Heart Diseases Patient Acceptance of Health Care Patient Participation Quality of Life Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94117, United States

Location status: Recruiting

About this study

The goal of this clinical trial study is to learn whether a digital multi-component intervention would increase the knowledge, self-efficacy, self-advocacy, and patient engagement skills of adults with congenital heart disease (CHD) to confidently navigate the health care system and have timely recommended specialist visits.

The multicomponent intervention contains features such as a digital medical passport, updated health-related specific information, opportunities to engage with CHD community, peer-support, doctor visit reminders, etc. The intervention components are designed with inputs from the patients and the CHD community and have the potential to be adapted on an ongoing basis depending on the needs of the patients.

The main question it aims to answer is:

Does the digital multi-component CHD patient engagement intervention enhance the patient engagement skills and lead to timely specialist visit?

Participants will be recruited from the clinics, through word of mouth, social media, and others. Participants can use the website link or a QR code to sign an electronic consent form to be eligible to participate. Once consented, the participants will receive surveys to collect baseline and health status information as well as intervention components at regular intervals. The study will be available for participants to join on the web or mobile, depending on their preferences.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • have congenital heart disease
  • 18 years or older
  • can sign the informed consent

Exclusion criteria

  • developmentally delayed
  • unable to consent

Treatment and study plan

Digital patient empowerment intervention

Behavioral

The intervention has features such as a digital medical passport, updated health-related information, community support and patient/peer stories and advice

Primary outcomes

  1. Recruitment rate

    Time frame: 6-12 months

    Number of patients recruited out of all the eligible patient approached for recruitment

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Patient activation measure (PAM)

    Time frame: 0, 6, 12 months

    The Patient Activation Measure® is a 13-item survey that assesses an individual's knowledge, skills and confidence integral to managing one's own health and healthcare. PAM generates a score along an empirical, interval-level scale from 0-100 that correlates to one of four levels of patient activation. PAM Levels 1 and 2 indicate lower patient activation, while PAM Levels 3 and 4 indicate higher patient activation.

  2. Gothenburg Empowerment Scale (GES)

    Time frame: 0, 6, 12 months

    Each question is scored on a 5-point Likert scale, with 1 = strongly disagree and 5 = strongly agree. A higher total score indicates a higher level of empowerment.

    The GES is a validated and reliable measure of patient empowerment in adults with CHD. It can be used to assess empowerment levels over time, to identify areas where empowerment can be improved, and to evaluate the effectiveness of interventions to promote empowerment.

  3. Timely specialist visit

    Time frame: 24 - 36 months

    Proportion with scheduled or completed ACHD specialist visits.

  4. Euro-Quality of Life

    Time frame: 0, 6, 12, and 24 months

    The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. Higher score indicates worse quality of life

Study contacts

Contact information is provided by the study sponsor or research team.

Anushree Agarwal, MBBS, MAS

CONTACT

[email protected]

415-353-3817

Sedona L Koenders, MS

CONTACT

[email protected]

(415) 547-0336

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Improving Care for Adults With Congenital Heart Disease

Acronym: EmpowerMyCH

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 3, 2024
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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