ArticleDigital health
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.
Article in Digital health. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06542575 (Efficacy of the Integration of Digital Therapeutics and Home-based Cardiac Rehabilitation in High-Risk Post-PCI Patients on Cardiovascular Health), which is not on this map. Not yet cited in PubMed.
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Efficacy of the Integration of Digital Therapeutics and Home-based Cardiac Rehabilitation in High-Risk Post-PCI Patients on Cardiovascular Health
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13 authors.
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Abstract
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).
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