Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 1, 2024
Date Accepted: Mar 21, 2024
Early Detection of Health Deterioration in Elderly Patients after Hospitalization for Heart Failure Decompensation - A potential Role for Ambient Sensor Systems in the Patients Home: Protocol for a Prospective Cohort Study
ABSTRACT
Background:
Home telemedicine (HTM) interventions in heart failure (HF) patients aim to reduce rehospitalization and mortality by early detection of acute HF. However, the effectiveness of home telemonitoring remains uncertain, with discrepancies between European and American guidelines. Wearable devices face challenges in compliance, especially among older adults. Ambient sensor systems (ASS) show promise in detecting early stages of acute HF.
Objective:
The primary objective of the study is to evaluate new digital biomarkers as predictors of impending acute HF (main study) and to quantify the correlation between refrigerator openings and protein intake (sub-study). The secondary objectives are (1) outcome assessment (rehospitalizations, cardiovascular death, all-cause death), (2) quality of life and (3) System Usability Scale (SUS).
Methods:
This prospective cohort study aims to include consecutive HF patients aged ≥70, living alone, and hospitalized for decompensation. ASS including physical activity, bathroom visits, and vital signs, are collected using a motion sensing system and a contact-free piezoelectric sensor. This commercially available passive infrared (PIR) motion sensing system (DomoHealth SA, Switzerland) collects sensor data from each room and two magnetic door sensors for entry-door and fridge-door openings that communicate wirelessly with a base unit. The sensor data are then visualized on a dedicated dashboard and the DomoCare® app for the investigator team for easily monitor the health and behavior of a system user. Digital biomarkers are evaluated for significant health deterioration, with confirmation through B-type natriuretic peptide (BNP) increase. Completion of the study if the number of 24 patients has been reached or if an interim analysis of the first 10 patients shows a sensitivity/specificity of the digital biomarkers for impending HF decompensation of ≤ 60% at the 3-month evaluation.
Results:
The study is in the data collection phase. Study recruitment is about to start by the end of January 2024. Data analysis is scheduled to start after all data are collected.
Conclusions:
This study addresses the limitations of previous HTM approaches by exploring ASS-derived digital biomarkers in elderly HF patients. Accurate prediction of HF decompensation could enable proactive management, potentially reducing healthcare costs associated with preventable emergency presentations or hospitalizations. The results are expected to offer insights into the effectiveness of ASS in an elderly HF population. Clinical Trial: NCT06126848
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