Digital Health Intervention to Promote Lifelong Specialized Care in Adults With Congenital Heart Disease: Theory-Driven Community Co-Designed Study.

Background: Adults with congenital heart disease frequently experience gaps in lifelong adult congenital heart disease (ACHD) specialty care, leading to preventable complications, hospitalizations, and premature mortality. However, effective, scalable, accessible, and sustainable strategies to reduce these gaps are lacking. Digital health offers potential solutions but requires a rigorous scientific approach in its design to address the needs of the target population. Objective: This study aims to describe the development of a theory-based, community co-designed digital health intervention to improve lifelong ACHD care. Methods: We integrated theory-based behavioral frameworks, semistructured qualitative interviews with patients and clinicians, and a community-engaged approach to develop a digital health intervention for ACHD. The primary behavioral target was completing an ACHD specialist appointment. We conducted Capability, Opportunity, Motivation, and Behavior (COM-B)-guided semistructured interviews with patients with ACHD and clinicians to identify barriers to specialized care amenable to a digital intervention, and patient-centered goals for the digital tool. The community partners helped develop key intervention objectives, create a theory-driven framework, and specify how each intervention component targets specific COM-B barriers. Results: We interviewed 54 participants (n=37 patients with ACHD, and n=17 clinicians) and engaged 21 community partners representing 4 advocacy organizations. Design objectives emphasized addressing patient loneliness, ensuring accessibility and credibility, and enabling scalability while centering patient perspectives. Participants identified 4 priorities: providing credible resources, uplifting patient voices, customizing to patient needs, and centering positivity and joy. The digital tool, named by community partners as Empower My Congenital Heart (EMCH), was designed within the web- and mobile-based, Apple- and Android-compatible, Eureka Digital Research platform (University of California, San Francisco). Key intervention components included educational modules, peer support, appointment planning nudges, and a digital medical passport. The EMCH's theory-driven framework specifies how each intervention component targets specific COM-B barriers to specialized ACHD care. Conclusions: The theory-driven, community co-designed EMCH digital tool provides a scalable approach to promote lifelong ACHD specialist care. Ongoing process evaluation and a planned randomized controlled trial will assess acceptability, engagement, and effectiveness in reducing care gaps. If proven effective, EMCH has the potential to prevent complications, emergency hospitalizations, and mortality affecting the majority of adults with congenital heart disease.