Currently accepted at: JMIR Rehabilitation and Assistive Technologies
Date Submitted: Aug 3, 2025
Date Accepted: Jun 1, 2026
This paper has been accepted and is currently in production.
It will appear shortly on 10.2196/81761
The final accepted version (not copyedited yet) is in this tab.
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Original Article: Randomised open label cross-over study comparing feasibility of S-patch vs 24 hour holter in Cognitively Impaired and Frail Older People with Falls
ABSTRACT
Background:
Falls commonly cause injury in older adults and can present with syncope or pre-syncope.Typically cognitively impaired and frail older patients are under represented in research studies and have difficulty tolerating longer periods of ECG monitoring. S-patch is a novel dual lead lightweight device and is well tolerated in older frail and cognitively impaired patients with falls.
Objective:
to compare the feasibility, tolerability, and efficacy of the S-Patch—a novel continuous heart rhythm monitoring device which enables up to 72 hours of ECG monitoring with standard 24-hour Holter monitor in cognitive impaired and older adults (≥60 years) presenting with unwitnessed falls, syncope, or near-syncope.
Methods:
A prospective, single-center, randomized, open-label, cross-over feasibility study was conducted from 8 March 2020 to 28 February 2023. Participants were randomized 1:1 into Group A (GpA), receiving Holter monitoring followed by the S-Patch, or Group B (GpB), receiving the S-Patch first followed by Holter.
Results:
Seventy patients were enrolled, 45.7% of whom had cognitive impairment. GpA participants were older (86.9 vs 82.9 years) and had greater usage of dementia medications (17.1% vs 8.6%). Detection rates for arrhythmia were comparable: Holter detected arrhythmias in 28.6% (GpA) and 48.6% (GpB), while the S-Patch detected 25.7% in both groups. One clinically significant arrhythmia was identified by both devices, resulting in pacemaker implantation. The S-Patch was worn longer in GpB (68.8 vs 62.9 hours, p=0.044) where S-patch was administered first. Frailty was common across groups: CFS 1–3 (17% vs 20%), CFS 4–5 (48.6% vs 54.3%), and CFS 6–9 (34.3% vs 25.7%). Fear of falling was significantly higher among frail patients (p=0.043).
Conclusions:
The S-Patch was well tolerated and demonstrated comparable performance to the Holter monitor in detecting arrhythmias in older, cognitively impaired patients and provided comparative rate and arrhythmia detection compared to 24 hour Holter Clinical Trial: 2019/2960 Comparison of Holter vs S-Patch for Arrhythmia Detection in Older Falls Patient
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Copyright
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