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Recruiting NCT06581484

Improving Congenital Heart Disease Care

No phase Interventional Congenital Heart Disease Behavior, Health Quality of Life Empowerment, Patient

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Digital patient empowerment intervention.
Who it may be relevant to
Registry conditions: Congenital Heart Disease, Behavior, Health, Quality of Life, Empowerment, Patient. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Improving Care for Adults With Congenital Heart Disease

Overview

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.

Interventions

  • 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

Primary outcome measures

  • 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]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • developmentally delayed
  • unable to consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of California, San Francisco — San Francisco

Identifiers

NCT: NCT06581484 · K23HL151866 · K23HL151866

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗