Evaluation of the efficacy of integrating digital therapeutics with home-based cardiac rehabilitation on cardiovascular health in high-risk post-PCI patients (DTx-HBCR): Study protocol for a randomized controlled trial

Background: Prior research has shown that home-based cardiac rehabilitation (HBCR) and center-based cardiac rehabilitation (CR) achieve comparable clinical outcomes in patients at low to moderate cardiovascular risk. However, the effectiveness of HBCR in high-risk patients remains uncertain. This study evaluates the efficacy of a DTx-integrated, multidisciplinary HBCR program as an alternative to usual care in high-risk patients following percutaneous coronary intervention (PCI). Methods: The DTx-HBCR trial is a parallel-arm, randomized controlled trial that will enroll 366 high-risk patients undergoing PCI at West China Hospital of Sichuan University. Participants will be randomly assigned in a 1:1 ratio to either a 6-month DTx-HBCR group (intervention group) or a 6-month usual care group (control group). Following the intervention period, both groups will be observed for an additional 6-month follow-up without active intervention. Outcome assessments will be conducted at baseline and at 3, 6, and 12 months post-randomization. The primary outcome is the between-group difference in functional capacity at 6 months, assessed by the 6-minute walk test. Key secondary outcomes include changes in cardiovascular health metrics (i.e., smoking status, blood pressure, glycosylated hemoglobin, lipid profile, body mass index, and physical activity), health-related quality of life, psychological well-being, and adherence to evidence-based cardioprotective medications. All analyses will be conducted according to the intention-to-treat principle. Conclusion: The DTx-HBCR trial is a novel randomized controlled clinical study designed to evaluate the efficacy of DTx-integrated HBCR program in improving functional capacity in high-risk patients following PCI. This DTx-integrated intervention has the potential to enhance cardiovascular health outcomes in this high-risk population. Trial registration: NCT06542575 (ClinicalTrials.gov).