Using smartphones and smartwatches to monitor disease course via the FLOODLIGHT app leads to high adherence and satisfaction among patients with multiple sclerosis (MS), results from a pilot study show.
The research, “Adherence and Satisfaction of Smartphone- and Smartwatch-Based Remote Active Testing and Passive Monitoring in People With Multiple Sclerosis: Nonrandomized Interventional Feasibility Study,” was published in the Journal of Medical Internet Research.
Assessing MS progression commonly requires periodic in-clinic visits, and doctors may miss subtle changes occurring between such visits.
Smartphones may be a solution for real-time data collection and better patient monitoring outside the clinic. The Roche-sponsored FLOODLIGHT study (NCT02952911) assessed the feasibility of using smartphones and smartwatches to assess MS symptoms, including hand function, gait and posture, mood, and cognitive impairment.
FLOODLIGHT primarily evaluated adherence and feedback to the smartphone- and smartwatch-based assessments, as well as the participants’ satisfaction, as determined by their impact on daily activities.
The study included 76 MS patients (ages 20 to 57; 53 were women) and 25 healthy controls, who were recruited at the Multiple Sclerosis Centre of Catalonia in Barcelona, and the University of California, San Francisco.
The test battery included active tests performed daily, weekly, every two weeks, or on demand for 24 weeks, and passive monitoring, which analyzed sensor-based gait and mobility. Participants were instructed to complete the active tests at roughly the same time every day, and to carry the smartphone and smartwatch with them all the time.
Adherence was assessed via the proportion of weeks with at least three days of completed testing, and four daily hours of passive monitoring. Satisfaction was determined through a questionnaire.
Clinical evaluations were conducted at the study’s start, after 12 weeks, and at the study’s end. Brain magnetic resonance imaging scans were taken at the enrollment visit and at week 24 (study’s end).
Most participants finished the study – 92% of MS patients and 64% of the controls. Reasons for discontinuation included the burden of continuous monitoring and lack of availability for the three required in-clinic visits.
Over an 18-month period, from November 2016 to April 2018, most participants performed five to seven active tests per week, including the Two-Minute Walk Test (2MWT). Adherence to both active tests and passive monitoring for the 24 weeks was good, and remained stable over time after week six. In the final week, participants had a minimum of four hours of passive monitoring data over an average of four days.
Adherence was higher for passive monitoring than the tests. Data showed that 70% of participants completed all active tests, 75% did all active tests except the 2MWT, and 79% had data collected via smartphone- or smartwatch-based passive monitoring.
The longer a person’s disease duration, the lower was their adherence. In contrast, disease severity was not seen to impact adherence.
Overall scores reflecting satisfaction was 73.7 out of 100 at week 24, having remained stable since week 12. Sixty-one patients reported that the test battery had an at least an acceptable impact on daily activities. Thirty-two had no issue with the active tests, while one-third would rather avoid the 2MWT.
A majority, 60%, of the MS patients said they would like to continue using the FLOODLIGHT app to better understand their disease and improve its management.
“Persons with multiple sclerosis were engaged and satisfied with the FLOODLIGHT test battery,” the scientists wrote. As such, “FLOODLIGHT sensor-based measures may enable continuous assessment of multiple sclerosis disease in clinical trials and real-world settings.”
FLOODLIGHT tests are being assessed in long-term studies with larger patient groups in the CONSONANCE Phase 3b trial of Ocrevus (ocrelizumab, by Roche-owned Genentech) in people with progressive MS (NCT03523858; still enrolling, contact information is here), and in a global study open to all MS patients with a mobile device, called FLOODLIGHT Open.
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