Improving Congenital Heart Disease Care (EmpowerMyCH)

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Congenital Heart Disease; Behavior, Health; Activation, Patient; Empowerment, Patient
• Intervention / Treatment: Behavioral: Digital patient empowerment 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 Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anushree Agarwal, MBBS, MAS; Phone Number: 415-353-3817; Email: anu.agarwal2@ucsf.edu
• Study Contact Backup: Name: Sedona L Koenders, MS; Phone Number: (415) 547-0336; Email: sedona.koenders@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94117
      • Recruiting
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• developmentally delayed
• unable to consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Number of patients recruited out of all the eligible patient approached for recruitment	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.	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.	0, 6 and 12 months
Feasibility of the intervention	Ability to download the app or any technical difficulties with the app or its features.	0, 6 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	0, 6, 12 months
Timely specialist visit	Proportion with scheduled or completed ACHD specialist visits.	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	0, 6, 12, and 24 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Anushree Agarwal, MBBS, MAS, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: August 19, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior; Treatment Adherence and Compliance; Patient Acceptance of Health Care; Heart Defects, Congenital; Health Behavior; Patient Participation
• Other Study ID Numbers: K23HL151866 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No