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).
Approach:
Study Design: Single-centre, randomised controlled trial involving 200 patients who underwent PCI, randomised 1:1 to receive SoC alone or SoC plus a 48-week gamified digital program.
Intervention: The digital program focused on lifestyle modification and remote patient monitoring (RPM), with high user retention and engagement.
Key Findings:
No significant difference in SMART2 risk scores between intervention and control groups at 6 months (adjusted mean difference −0.3%; P = 0.821).
Significant improvement in disease knowledge at 6 and 12 months (P < 0.001) and medication adherence at 6 months (P = 0.030) in the intervention group.
Diastolic blood pressure was significantly lower in the intervention group at 12 months (−3.7 mmHg; P = 0.003).
In overweight participants, the intervention significantly reduced SMART2 scores at 12 months compared to controls (−3.7%; P = 0.033).
Interpretation:
The intervention did not reduce the SMART2 risk score in the overall population but improved disease knowledge, medication adherence, and diastolic blood pressure.
Limitations:
Single-centre study may limit generalizability.
Blinding was not feasible due to the nature of the intervention.
Conclusion:
The program was well-accepted and may offer prognostic benefits for overweight patients.
by Elias Freyr Gudmundsson, Bartosz Dobies, Brynja Laxdal, Inga Valborg Olafsdottir, Ingibjörg Davidsdottir, Heida Birna Bragadottir, Svala Sigurdardottir, Ari Pall Isberg, Andrew Grannell, Berglind Libungan, Brynjolfur A. Mogensen, Hulda Halldorsdottir, Maria V. Gudmundsdottir, Bylgja Kaernested, Tryggvi Thorgeirsson, Saemundur Jon Oddsson, David O. Arnar
