Adherence and Satisfaction of Smartphone- and Smartwatch-Based Remote Active Testing and Passive Monitoring in People With Multiple Sclerosis: Nonrandomized Interventional Feasibility Study

Abstract

Background: Current clinical assessments of people with multiple sclerosis are episodic and may miss critical features of functional fluctuations between visits.

Objective: The goal of the research was to assess the feasibility of remote active testing and passive monitoring using smartphones and smartwatch technology in people with multiple sclerosis with respect to adherence and satisfaction with the FLOODLIGHT test battery.

Methods: People with multiple sclerosis (aged 20 to 57 years; Expanded Disability Status Scale 0-5.5; n=76) and healthy controls (n=25) performed the FLOODLIGHT test battery, comprising active tests (daily, weekly, every two weeks, or on demand) and passive monitoring (sensor-based gait and mobility) for 24 weeks using a smartphone and smartwatch. The primary analysis assessed adherence (proportion of weeks with at least 3 days of completed testing and 4 hours per day passive monitoring) and questionnaire-based satisfaction. In-clinic assessments (clinical and magnetic resonance imaging) were performed.

Results: People with multiple sclerosis showed 70% (16.68/24 weeks) adherence to active tests and 79% (18.89/24 weeks) to passive monitoring; satisfaction score was on average 73.7 out of 100. Neither adherence nor satisfaction was associated with specific population characteristics. Test-battery assessments had an at least acceptable impact on daily activities in over 80% (61/72) of people with multiple sclerosis.

Conclusions: People with multiple sclerosis were engaged and satisfied with the FLOODLIGHT test battery. FLOODLIGHT sensor-based measures may enable continuous assessment of multiple sclerosis disease in clinical trials and real-world settings.

Trial registration: ClinicalTrials.gov: NCT02952911; https://ichgcp.net/clinical-trials-registry/NCT02952911.

Keywords: mobile phone; multiple sclerosis; patient adherence; patient satisfaction; smartphone; wearable electronic devices.

Conflict of interest statement

Conflicts of Interest: XM has received speaker honoraria and travel expense reimbursement for participation in scientific meetings, been a steering committee member of clinical trials, or served on advisory boards of clinical trials for Actelion, Biogen, Celgene, Merck, Novartis, Oryzon, Roche, Sanofi Genzyme, and Teva Pharmaceutical. JG has received grants or research support from Biogen, Genentech Inc, and S3 Group and has received compensation for a nonbranded resident and fellow education seminar supported by Biogen. SLH serves on the scientific advisory boards for Annexon, Symbiotix, Bionure, and Molecular Stethoscope, is on the board of trustees for Neurona Therapeutics, and has received travel reimbursement and writing assistance from F Hoffmann–La Roche Ltd for CD20-related meetings and presentations. LJ is an employee of Genentech Inc and a shareholder of F Hoffmann–La Roche Ltd. MB, JS, and CG are employees and shareholders of F Hoffmann–La Roche Ltd. AS, FL, and JvB are employees of F Hoffmann–La Roche Ltd. CB and ML are contractors for F Hoffmann–La Roche Ltd. SB was an employee of F Hoffmann–La Roche Ltd during the completion of the work related to this manuscript. SB is now an employee of Biogen (Cambridge, MA), which was not in any way associated with this study. LM and PM have nothing to disclose.

©Luciana Midaglia, Patricia Mulero, Xavier Montalban, Jennifer Graves, Stephen L Hauser, Laura Julian, Michael Baker, Jan Schadrack, Christian Gossens, Alf Scotland, Florian Lipsmeier, Johan van Beek, Corrado Bernasconi, Shibeshih Belachew, Michael Lindemann. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 30.08.2019.

Figures

Figure 1

FLOODLIGHT study design. PRO: patient-reported outcome. "a" indicates that active tests were administered weekly or every two weeks (see next figure for schedule). "b" indicates that brain magnetic resonance imaging was performed in people with multiple sclerosis.

Figure 2

FLOODLIGHT active tests and their schedule frequency. DMQ: Daily Mood Question; MSIS-29: Multiple Sclerosis Impact Scale–29; SBT: Static Balance Test; SDMT: Symbol Digit Modalities Test; ST: Symptom Tracker; 2MWT: Two-Minute Walk Test; 5UTT: 5 U-Turn Test.

Figure 3

Adherence of people with multiple sclerosis to active tests for individual participants: number of performed active tests per week [level of activity (light green: high; dark green/grey: low] over individual study weeks [columns]).

Figure 4

Adherence of people with multiple sclerosis to active tests. 2MWT: Two-Minute Walk Test.

Figure 5

Adherence of people with multiple sclerosis to smartphone and smartwatch passive monitoring. Days with more than 4 hours of passive monitoring on a device are considered as adherent.

Figure 6

Adherence of people with multiple sclerosis to active tests and passive monitoring. The results of the time-to-event survival analysis based on the Kaplan–Meier method along the FLOODLIGHT study. The abandoning event was defined as the last week in which the participant was adherent according to the definitions for active tests and passive monitoring. Active tests performed on days of in-clinic visits were not considered in the adherence calculation, to focus the abandoning analysis on the remote use. Participants leaving the study before the terminal visit were considered as censored. 2MWT: Two-Minute Walk Test.

Figure 7

Implications of FLOODLIGHT in people with multiple sclerosis for “impact on daily activities” from the patient satisfaction questionnaire.

Figure 8

Implications of FLOODLIGHT in people with multiple sclerosis for “avoiding one component of FLOODLIGHT" from the patient satisfaction questionnaire. 2MWT: Two-Minute Walk Test.

Figure 9

Implications of FLOODLIGHT in people with multiple sclerosis for “desire to continue using the FLOODLIGHT app” from the patient satisfaction questionnaire.

Figure 10

Implications of FLOODLIGHT in people with multiple sclerosis for “prefer to see results immediately to monitor” from the patient satisfaction questionnaire.