Improving Congenital Heart Disease Care

NCT06581484 | Recruiting

• 1 other identifier: K23HL151866
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Congenital Heart Disease; Behavior, Health; Quality of Life; Empowerment, Patient; Activation, Patient

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Patient activation measure (PAM)

  0, 6, 12 months

• Gothenburg Empowerment Scale (GES)

  0, 6, 12 months

• Timely specialist visit

  24 - 36 months

• Euro-Quality of Life

  0, 6, 12, and 24 months

Study Arms (1)

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

Behavioral: Digital patient empowerment intervention

Interventions

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• developmentally delayed
• unable to consent

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94117, United States

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital; Health Behavior; Patient Participation

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior; Patient Acceptance of Health Care; Treatment Adherence and Compliance

Study Officials

• Anushree Agarwal, MBBS, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anushree Agarwal, MBBS, MAS

CONTACT

415-353-3817; anu.agarwal2@ucsf.edu

Sedona L Koenders, MS

CONTACT

(415) 547-0336; sedona.koenders@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: September 3, 2024
• Study Start: September 5, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)