Heart failure rehospitalization prevention by IoT monitoring: feasibility study protocol

Background: Heart failure hospitalizations result in approximately a quarter of patients being readmitted within a year of discharge in Japan. Telemonitoring of home-measured values related to heart failure, such as home blood pressure may reduce the rate of readmission by allowing early detection of deterioration and directing toward amelioration by interventions other than hospitalization. Primary objective of the study will be to assess the efficacy of home monitoring of blood pressure, body weight, body temperature, and oxygen saturation, with team care, in the prevention of heart failure rehospitalization.

Methods: This will be a single-arm, prospective, open-label, single-institution feasibility study with a recruitment period of 1 year and an observation period of 1 year using historical control. Target population will be adult patients hospitalized for chronic or acute heart failure of any cause with ejection fraction less than 50% at some time during hospitalization. Eligible patients will be notified of the study, and those who gave informed consent will receive the monitoring devices (Omron Healthcare, Obniz) and set up support from the local study staff. Study staff will monitor the values measured at home and alert the patients and/or family members according to the protocol predetermined and adjusted for each patient. When necessary, local staff will escalate the detailed information to principal doctor and/or care providers for medical interventions such as dose adjustments. Telemonitoring and telemedicine platform, including an app for patients and dashboard for care team, will be provided. The primary outcome will be the rate of readmission for the whole group followed for a year after discharge. Expected sample size is about 20 patients for this study.

Results: The results will be analyzed to plan further research.

Conclusion: This feasibility and proof-of-concept study on the use of multiple-IoT device-monitoring may address the problem of heart failure readmissions and shape the future of heart failure team care.

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