Frontiers in digital health · 2026
Use of a digital health solution after percutaneous coronary intervention: a randomised controlled trial.
Клиническое исследованиеСтатьяНазвание и аннотация: Перевод в очереди
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Gudmundsson Elias Freyr, Dobies Bartosz, Laxdal Brynja, Olafsdottir Inga Valborg, Davidsdottir Ingibjörg, Bragadottir Heida Birna, Sigurdardottir Svala, Isberg Ari Pall, Grannell Andrew, Libungan Berglind, Mogensen Brynjolfur A, Halldorsdottir Hulda, Gudmundsdottir Maria V, Kaernested Bylgja, Thorgeirsson Tryggvi, Oddsson Saemundur Jon, Arnar David O
Аннотация
AIMS: To evaluate a multimodal digital health intervention (SK-121) as an adjunct to standard of care (SoC) to reduce the risk of recurrent cardiovascular events in patients following percutaneous coronary intervention (PCI).
METHODS AND RESULTS: In this single-centre, randomised controlled trial of 200 patients (mean age 64.4 years; 79.5% male) who underwent PCI, patients were randomised 1:1 to receive SoC alone or SoC plus a 48-week gamified digital program focusing on lifestyle modification and remote patient monitoring (RPM). User retention and engagement were high with 84% remaining active at 24 weeks and weekly RPM completion averaging 94%. The primary endpoint was the baseline-adjusted between-group difference in the Second Manifestations of ARTerial disease, version 2 (SMART2) risk score at 6 months. These SMART2 scores did not differ between the intervention and control groups (adjusted mean difference -0.3%; 95% confidence interval -2.4% to 1.9%; P = 0.821). However, the intervention group significantly improved in disease knowledge at 6 and 12 months (P < 0.001) and medication adherence at 6 months (P=0.030). Diastolic blood pressure was significantly lower in the intervention group at 12 months (-3.7 mmHg; P = 0.003). In a post hoc exploratory hypothesis-generating subgroup analysis of overweight participants, the intervention significantly reduced SMART2 scores at 12 months compared to controls (-3.7%; P = 0.033).
CONCLUSION: While the intervention did not reduce the SMART2 risk score in the overall population, it significantly improved disease knowledge, short-term medication adherence, and diastolic blood pressure. The program was well-accepted and may offer prognostic benefits for overweight patients.
CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/study/NCT05713565, NCT05713565.
METHODS AND RESULTS: In this single-centre, randomised controlled trial of 200 patients (mean age 64.4 years; 79.5% male) who underwent PCI, patients were randomised 1:1 to receive SoC alone or SoC plus a 48-week gamified digital program focusing on lifestyle modification and remote patient monitoring (RPM). User retention and engagement were high with 84% remaining active at 24 weeks and weekly RPM completion averaging 94%. The primary endpoint was the baseline-adjusted between-group difference in the Second Manifestations of ARTerial disease, version 2 (SMART2) risk score at 6 months. These SMART2 scores did not differ between the intervention and control groups (adjusted mean difference -0.3%; 95% confidence interval -2.4% to 1.9%; P = 0.821). However, the intervention group significantly improved in disease knowledge at 6 and 12 months (P < 0.001) and medication adherence at 6 months (P=0.030). Diastolic blood pressure was significantly lower in the intervention group at 12 months (-3.7 mmHg; P = 0.003). In a post hoc exploratory hypothesis-generating subgroup analysis of overweight participants, the intervention significantly reduced SMART2 scores at 12 months compared to controls (-3.7%; P = 0.033).
CONCLUSION: While the intervention did not reduce the SMART2 risk score in the overall population, it significantly improved disease knowledge, short-term medication adherence, and diastolic blood pressure. The program was well-accepted and may offer prognostic benefits for overweight patients.
CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/study/NCT05713565, NCT05713565.