Digital Health Intervention to Promote Lifelong Specialized Care in Adults With Congenital Heart Disease: Theory-Driven Community Co-Designed Study
Clinical Snapshot
PICO Framework
| P — Population | Adults with congenital heart disease (ACHD) experiencing gaps in lifelong ACHD specialist care, and clinicians involved in ACHD management |
| I — Intervention | Development process of a theory-driven, community co-designed digital health intervention (Empower My Congenital Heart; EMCH) incorporating COM-B behavioural framework, semistructured qualitative interviews, and community-engaged co-design |
| C — Comparator | No comparator — this is an intervention development and design study, not a comparative effectiveness study |
| O — Outcomes | Identification of barriers to ACHD specialist care amenable to digital intervention; patient-centred design priorities; specification of intervention components mapped to COM-B barriers; development of a scalable digital tool targeting completion of ACHD specialist appointments |
Bottom Line
This study describes the rigorous, theory-driven co-design of a digital health tool (EMCH) to address care gaps in adults with congenital heart disease — a growing population at risk of preventable complications and premature mortality. Using the validated COM-B behavioural framework and meaningful community co-design with patients, clinicians, and advocacy organisations, the authors identified four patient-centred design priorities and mapped intervention components to specific behavioural barriers. The resulting tool includes educational modules, peer support, appointment nudges, and a digital medical passport, delivered via a cross-platform mobile and web application. This is a well-conceived intervention development study with strong theoretical grounding and genuine community engagement. However, clinicians should note that EMCH remains untested — no efficacy or clinical outcome data exist yet. The planned RCT will be critical. Key methodological gaps include absent reflexivity reporting, unclear sampling and saturation criteria, and limited demographic data on participants. For Australian ACHD clinicians, the geographic accessibility and scalability features are particularly relevant given the concentration of specialist services in metropolitan centres. EMCH represents a promising but preliminary step; clinical adoption should await RCT evidence.
Key Findings
Effect Size: Not applicable — qualitative intervention development study; no quantitative effect size reported
Primary Outcome: Identification of four patient-centred design priorities for the EMCH digital tool: (1) providing credible resources, (2) uplifting patient voices, (3) customising to patient needs, and (4) centring positivity and joy. Design objectives emphasised addressing patient loneliness, ensuring accessibility and credibility, and enabling scalability.
Nnt Or Sensitivity: Not applicable — intervention development phase only; clinical effectiveness outcomes (care gap reduction, hospitalisation rates) are planned for assessment in a future RCT
Clinical Application
The EMCH tool is designed for web and mobile platforms (Apple and Android), which supports broad accessibility. Deployment on the established Eureka Digital Research Platform (UCSF) provides a validated technical infrastructure. Key components — educational modules, peer support, appointment planning nudges, and a digital medical passport — are clinically intuitive and low-burden. Feasibility in real-world implementation will depend on digital literacy, language accessibility, and integration with existing ACHD clinic workflows. Scalability is a stated design priority, though resource requirements for ongoing platform maintenance and peer support moderation are not addressed. Australia has an estimated 65,000–75,000 adults living with congenital heart disease, with significant care gaps particularly in rural and remote regions. ACHD specialist services are concentrated in major metropolitan centres (Sydney, Melbourne, Brisbane, Perth), creating geographic barriers analogous to those described in this study. The RACGP supports digital health integration for chronic disease management, and the Australian Digital Health Agency's national digital health strategy aligns with the scalability goals of EMCH. A digital medical passport component has direct relevance to Australian patients who frequently transition between state-based health systems. PBS implications are indirect at this stage — no pharmacological intervention is involved — but reducing preventable ACHD hospitalisations has significant cost implications for the Australian hospital system. TGA oversight would apply if EMCH were classified as a Software as a Medical Device (SaMD) under Australian regulatory frameworks, which warrants consideration prior to any Australian deployment. The RACGP and CSANZ (Cardiac Society of Australia and New Zealand) would be relevant bodies for guideline alignment. Adults with congenital heart disease (all complexity levels) who have lapsed from or never established ACHD specialist care. Particularly relevant for patients transitioning from paediatric to adult cardiology services, those in geographically remote areas, and those with limited health literacy or psychosocial barriers to engagement.
Abstract
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.
References
- 1.Agarwal, A., Valente, J., Buenrostro, K., Macholl, K., Mehta, J., Reddy, K., Manayan, K., Kim, P., Sparks, A., Li, K., Ahuja, P., Sun, K., Payton, K., Norris, M. D., Bravo-Jaimes, K., Reardon, L., Moons, P., Okumura, M. J., Marcus, G. M., & Gurvitz, M. (2026). Digital health intervention to promote lifelong specialized care in adults with congenital heart disease: Theory-driven community co-designed study. Journal of Medical Internet Research. https://doi.org/10.2196/75867
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