This is a protocol for a trial testing whether a smartphone app for secondary prevention improves adherence and quality of life in patients with chronic coronary syndrome compared to standard care.
European Heart Journal. Digital Health · 12 authors, 12 centres
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This is a protocol for a trial testing whether a smartphone app for secondary prevention improves adherence and quality of life in patients with chronic coronary syndrome compared to standard care.
The CHANGE study is a prospective, randomized, controlled, multicentre trial protocol evaluating a smartphone application (VantisTherapy) as an adjunct to standard care for secondary prevention in patients with chronic coronary syndrome (CCS). The study plans to randomize 210 patients from nine German centres to either standard care alone or standard care plus the app, with outcomes assessed at 0, 12, and 24 weeks. The primary outcomes are adherence to secondary prevention recommendations and quality of life. The study is open-label, and a limitation is the absence of a placebo-app for the control group, which could affect blinding. Another noted limitation is that long-term effects of the intervention may diminish after the trial concludes.