Improving Congenital Heart Disease Care

NCT ID: NCT06581484

Last Updated: 2026-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-05

Study Completion Date

2027-08-31

Brief Summary

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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

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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

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Digital patient empowerment intervention

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* developmentally delayed
* unable to consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anushree Agarwal, MBBS, MAS

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Anushree Agarwal, MBBS, MAS

Role: CONTACT

415-353-3817

Sedona L Koenders, MS

Role: CONTACT

(415) 547-0336

Other Identifiers

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K23HL151866

Identifier Type: NIH

Identifier Source: secondary_id

View Link

K23HL151866

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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