Key Points:
- Health360x.ai is an AI-powered digital health platform designed to scale access to decentralized clinical trials (DCTs) by addressing infrastructure gaps in small and medium-sized practices.
- Across 35 community-based sites, the registry enrolled 7,513 participants: 85% Black, 8% White, 58% female, and 15% from rural areas. Over half (51%) reported annual income <$25,000.
- High adoption metrics included a 95% usability score and strong engagement with chatbot tools and site team training (p<0.02 vs baseline).
Addressing the persistent lack of diversity in clinical trials, Dr. Elizabeth Ofili and colleagues presented results from the Health360x.ai Registry during the Late-Breaking Clinical Trials session at ACC 2025. The platform, developed under an NIH Fast-Track SBIR grant, aims to enable point-of-care access to decentralized clinical trials (DCTs) through AI integration and targeted support for resource-limited practices. The authors hypothesized that a point of care research registry platform could scale decentralized clinical trials (DCT) for efficient and sustainable access to clinical trials, by systematically addressing gaps in the practice infrastructure of community physicians. They implemented the Health360x_Registry integrating social determinants in communities serving predominantly African Americans, Latinx, and patients from rural communities
The study enrolled 7,513 participants across 35 community-based sites participating in 4 NIH-sponsored and 1 industry-sponsored study. The median age was 70 years, with 85% identifying as Black, 8% as White, and 58% as female. Notably, 15% of participants were from rural areas and 51% reported annual incomes below $25,000—highlighting the platform’s reach into underserved populations.
Health360x.ai uses machine learning algorithms to analyze EHR data and identify eligible participants for ongoing studies. Additional features include a chatbot for collecting social determinants of health (SDOH) via PhenX surveys, and dashboards that enable real-time tracking of recruitment by diagnosis.
Qualitative analysis of focus groups and interviews revealed strong engagement with the platform’s AI-powered tools: 75% of responses referenced the chatbot, and 85% emphasized the importance of site team training and optimized research workflows (p<0.02 vs baseline). The system’s usability was rated at 95%.
The Health360x.ai model has proven effective even in previously research-naïve practices, successfully onboarding them into high-quality clinical research. According to the investigators, next steps will include expanded AI automation for site training and recruitment, as well as advanced analytics to capture the multidimensional health profiles of enrolled patients.