Clinical trial NCT06581484: Improving Congenital Heart Disease Care
Official title: Improving Care for Adults With Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Congenital Heart Disease
Behavior, Health
Quality of Life
Empowerment, Patient
Activation, Patient
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-09-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* developmentally delayed
* unable to consent

Primary outcomes:
measure: Recruitment rate
timeFrame: 6-12 months
measure: Satisfaction with the intervention components
timeFrame: 0, 6 and 12 months
measure: Acceptability of the intervention components
timeFrame: 0, 6 and 12 months
measure: Feasibility of the intervention
timeFrame: 0, 6 and 12 months
Secondary outcomes:
measure: Patient activation measure (PAM)
timeFrame: 0, 6, 12 months
measure: Gothenburg Empowerment Scale (GES)
timeFrame: 0, 6, 12 months
measure: Timely specialist visit
timeFrame: 24 - 36 months
measure: Euro-Quality of Life
timeFrame: 0, 6, 12, and 24 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Anushree Agarwal, MBBS, MAS
role: PRINCIPAL_INVESTIGATOR
References: