Improving Congenital Heart Disease Care
NCT Number: NCT06581484
Acronym: EmpowerMyCH
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Congenital Heart Disease|Behavior, Health|Quality of Life|Empowerment, Patient|Activation, Patient
Interventions: BEHAVIORAL: Digital patient empowerment intervention
Sponsor: University of California, San Francisco
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-30
Completion Date: 2034-12-31
Locations: University of California, San Francisco, San Francisco, California, 94117, United States

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.

Primary Outcome Measures: 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 Outcome Measures: Patient activation measure (PAM), The Patient Activation Measure® is a 13-item survey that assesses an individual's knowledge, skills and confidence integral to managing one's own health and healthcare. PAM generates a score along an empirical, interval-level scale from 0-100 that correlates to one of four levels of patient activation. PAM Levels 1 and 2 indicate lower patient activation, while PAM Levels 3 and 4 indicate higher patient activation., 0, 6, 12 months|Gothenburg Empowerment Scale (GES), Each question is scored on a 5-point Likert scale, with 1 = strongly disagree and 5 = strongly agree. A higher total score indicates a higher level of empowerment.

The GES is a validated and reliable measure of patient empowerment in adults with CHD. It can be used to assess empowerment levels over time, to identify areas where empowerment can be improved, and to evaluate the effectiveness of interventions to promote empowerment., 0, 6, 12 months|Timely specialist visit, Proportion with scheduled or completed ACHD specialist visits., 24 - 36 months|Euro-Quality of Life, The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. Higher score indicates worse quality of life, 0, 6, 12, and 24 months