Remote patient monitoring and digital therapeutics in heart failure: lessons from the Continuum pilot study

Introduction: The increasing use of digital health solutions to monitor heart failure (HF) outpatients has been driven by the COVID-19 pandemic. An ideal technology should answer the specific needs of a public healthcare system: easy integration and proof of clinical benefit to justify investment in its long-term use. Through a consortium bringing together patients, physicians, industry, and hospital organizations, we developed a digital solution called Continuum, targeting patients with HF and other comorbidities. Hypothesis: A digital health solution combining remote patient monitoring (RPM) and digital therapeutics (DTx) was developed to ensure a better follow-up of patients and to rapidly optimize their medication and subsequently avoid future severe adverse events. Methods: A pilot intervention/control study with a three-month follow-up was conducted. Patients in the intervention group (remote patient monitoring group, RPM+) had a smartphone or tablet and entered in their mobile app their vital signs, weight, and HF symptoms daily. HF patients who either did not have a mobile device or the skills to use the app were enrolled in the control group (RPM-). The HealthCare Professionals (HCPs) used a web-based dashboard to follow the RPM+ patients. They could access the results of a DTx solution to help them optimize the HF treatment according to Canadian guidelines. Results: 52 HF patients were enrolled in this study, 32 in the RPM+: 69+/-9y age, 75% male, ejection fraction 42 +/- 14%. In the RPM- group, more patients had at least one hospitalization (all-cause) compared to the RPM+ group (35% versus 6% respectively; p=0.008). Similarly, the number of patients with at least one HF hospitalization was more significant in the RPM+ group compared to the RPM- (25% versus 6%, p=0.054). Finally, the intervention showed a medium effect on HF treatment optimization (w=0.26) and quality of life for the most compliant patients to the intervention (g=0.48). Conclusion: The results of this pilot study demonstrated the feasibility of an intervention combining RPM and DTx solutions for HF patients. Preliminary results suggest promising impacts on quality of life, hospitalizations, and patients' medication optimization. However, they need to be confirmed in a more extensive study. Keywords: chronic heart failure, telemonitoring, digital therapeutics, software as medical device (SAMD), remote patient management, digital health, mobile health, algorithms