Trials. 2026 Feb 20. doi: 10.1186/s13063-026-09564-z. Online ahead of print.
ABSTRACT
BACKGROUND: Cardiovascular (CV) disease and its risk factors such as hypertension, diabetes, and hyperlipidemia account for most chronic diseases experienced by adults in the US. The use of text-based "behavioral nudges" supports behavior change and self-management of chronic disease. Building upon our previous trial utilizing an artificially intelligent (AI) chatbot for medication adherence, the Chat for Heart Health randomized controlled trial aims to test the comparative effectiveness of 3 text-based methods of delivering "nudges" to change health behaviors to reduce cardiovascular disease risk in patients across 3 safety-net healthcare systems.
METHODS: Adult patients ages 18-89 with CV risk factors will be recruited from 3 health systems. A target of 2097 participants will be randomized to 3 study arms: generic text messaging, AI interactive chatbot messaging, and AI interactive chatbot messaging plus pharmacist support. Evaluation of the intervention and the program will be carried out using the RE-AIM and PRISM frameworks. The primary effectiveness outcome is the change in CV risk reduction behaviors as defined by the American Heart Association's Life's Essential 8 score. Secondary outcomes including patient self-efficacy scores, clinical events, healthcare utilization, and facilitators and barriers to implementation and adoption will also be assessed.
DISCUSSION: Our large-scale pragmatic trial engages with patients and health systems who have traditionally not engaged in research, which presented substantial challenges yet will make our results more generalizable to diverse populations. Additionally, we engaged a diverse advisory panel made up of patients, community members, providers, and health systems leaders throughout the study to ensure sociocultural, linguistic, and community relevance. The results of this trial (if the intervention is effective) could lead to broader dissemination of a low-cost intervention to support behavior change to reduce CV risk.
TRIAL REGISTRATION: NCT06324981 (3/14/2024), https://clinicaltrials.gov/study/NCT06324981.
PMID:41721367 | DOI:10.1186/s13063-026-09564-z