Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Jan 18, 2019
Date Accepted: Sep 26, 2019
Exploring the Feasibility of Using Biotelemetry to Monitor Patients with Amyotrophic Lateral Sclerosis During Clinical Trials
ABSTRACT
Background:
Biotelemetric monitoring of patients with Amyotrophic Lateral Sclerosis (ALS) has the potential to provide an important source of information to evaluate the impact of the disease on aspects of real-world functional capacity and activities of daily living in the home setting, and providing useful objective outcome measures for clinical trials.
Objective:
To investigate the feasibility of a novel digital platform for remote data collection of multiple symptoms (physical activity, heart-rate variability (HRV) and digital speech characteristics) in 25 patients with ALS in an observational clinical trial setting, to explore the impact of the devices on patients’ everyday life and to record tolerability related to the devices and study procedures over 48 weeks.
Methods:
In this exploratory, non-controlled, non-drug study (NCT02447952), patients attended a clinical site visit every 3 months to perform activity reference tasks while wearing a biotelemetry sensor, to conduct digital speech tests and for conventional ALS monitoring. Additionally, patients wore the sensor in their daily life for approximately 3 days every month for the duration of the study.
Results:
The amount and quality of digital speech data captured at the clinical sites was as intended and there were no significant issues. All the biotelemetry home-monitoring data available propagated through the system and were received as expected. However, the amount and quality of physical activity home-monitoring data were lower than anticipated. Three or more days (or partial days) of data were recorded for 65% of protocol time points, with no data collected for 24% of time points. At baseline, 24 of 25 patients provided data; reduced to 13 of 18 patients at Week 48. Lower-than-expected quality HRV data was obtained, likely due to poor contact between the sensor and the skin. Six of 25 patients had mild or moderate adverse events (AEs) in the skin and subcutaneous tissue disorders category due to skin irritation by the electrode patch. There were no reports of serious AEs or deaths. Most patients found the sensor comfortable with no or minimal impact on daily activities.
Conclusions:
The biotelemetry platform can measure physical activity in patients with ALS in their home environment; patients used the equipment successfully and it was generally well tolerated. The quantity of home-monitoring physical activity data was lower than expected, although it was still sufficient to allow investigation of novel physical activity endpoints. Good quality in-clinic speech data was successfully captured for analysis. Overall, the biotelemetry platform feasibility review revealed significant promise, and future studies using the novel biotelemetry and home-monitoring approaches, combined with the most current technological advances, may be useful to elucidate novel digital biomarkers of disease progression.
Citation
