Congenital Heart DiseaseEmpowerMyCHNCT06581484
Improving Congenital Heart Disease Care
A study testing Digital patient empowerment intervention in people with Congenital Heart Disease and Behavior, Health, run by University of California, San Francisco at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Heart Disease, Behavior, Health, Quality of Life
- What is being tested?
- Digital patient empowerment intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2024to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have congenital heart disease
- 18 years or older
- can sign the informed consent
Who cannot join
- developmentally delayed
- unable to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94117
About this study
Official title: Improving Care for Adults With Congenital Heart Disease
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.
Read the detailed description
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.
- Conditions
- Congenital Heart Disease, Behavior, Health, Quality of Life, Empowerment, Patient, Activation, Patient
- Being tested
- Digital patient empowerment intervention
- Medical subject headings
- Heart Defects, Congenital, Health Behavior, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital patient empowerment interventionBehavioural
The intervention has features such as a digital medical passport, updated health-related information, community support and patient/peer stories and advice
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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 Receives: Behavioral: Digital patient empowerment intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number of patients recruited out of all the eligible patient approached for recruitment
Measured: 6-12 months
Satisfaction with the intervention components
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.
Measured: 0, 6 and 12 months
Acceptability of the intervention components
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.
Measured: 0, 6 and 12 months
Feasibility of the intervention
Ability to download the app or any technical difficulties with the app or its features.
Measured: 0, 6 and 12 months
Secondary outcomes (4)
Patient activation measure (PAM)
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.
Measured: 0, 6, 12 months
Gothenburg Empowerment Scale (GES)
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.
Measured: 0, 6, 12 months
Timely specialist visit
Proportion with scheduled or completed ACHD specialist visits.
Measured: 24 - 36 months
Euro-Quality of Life
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
Measured: 0, 6, 12, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start5 Sep 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Anushree Agarwal, MBBS, MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581484
- Sponsor's protocol ID
- K23HL151866
- Other IDs
- K23HL151866
- Acronym
- EmpowerMyCH
- Status last verified
- Jan 2026
- First submitted
- 19 Aug 2024
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Care for Adults With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT06581484
- Acronym / sponsor ID
- EmpowerMyCH / K23HL151866
- Conditions
- Congenital Heart Disease, Behavior, Health, Quality of Life, Empowerment, Patient, Activation, Patient
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Digital patient empowerment interventionThis 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- have congenital heart disease
- 18 years or older
- can sign the informed consent
Key exclusion criteria (2 listed)
- developmentally delayed
- unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital patient empowerment interventionThe intervention has features such as a digital medical passport, updated health-related information, community support and patient/peer stories and advice | Behavioural | Intervention |
Primary outcome
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.
4 secondary outcomes
Patient activation measure (PAM)
Time frame: 0, 6, 12 months
Gothenburg Empowerment Scale (GES)
Time frame: 0, 6, 12 months
Timely specialist visit
Time frame: 24 - 36 months
Euro-Quality of Life
Time frame: 0, 6, 12, and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anushree Agarwal, MBBS, MAS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital patient empowerment intervention in people with Congenital Heart Disease and Behavior, Health, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anushree Agarwal, MBBS, MAS (415-353-3817, anu.agarwal2@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 6-12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.