Recruiting

Congenital Heart Disease

Sponsor:

UCLA

Code:

NCT06581484

Conditions

Congenital Heart Disease

Behavior, Health

Quality of Life

Empowerment, Patient

Activation, Patient

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Digital patient empowerment intervention

Study Details

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

Study ID

NCT06581484

Start date

Sep 5, 2024

Status verified date

Jan, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • developmentally delayed
  • unable to consent

Study Design

Enrollment

1000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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

Interventions

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 measure

  • Recruitment rate [ Time Frame: 6-12 months ]
  • Satisfaction with the intervention components [ Time Frame: 0, 6 and 12 months ]
  • Acceptability of the intervention components [ Time Frame: 0, 6 and 12 months ]
  • Feasibility of the intervention [ Time Frame: 0, 6 and 12 months ]

Central Contacts and Locations

Central contacts

Anushree Agarwal, MBBS, MAS

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

Sedona L Koenders, MS

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

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94117

More Information

Sponsor

University of California, San Francisco

Last update posted

Jan 23, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-01-23.