Reliability and acceptance of dreaMS, a software application for people with multiple sclerosis: a feasibility study

Tim Woelfle, Silvan Pless, Oscar Reyes, Andrea Wiencierz, Anthony Feinstein, Pasquale Calabrese, Konstantin Gugleta, Ludwig Kappos, Johannes Lorscheider, Yvonne Naegelin, Tim Woelfle, Silvan Pless, Oscar Reyes, Andrea Wiencierz, Anthony Feinstein, Pasquale Calabrese, Konstantin Gugleta, Ludwig Kappos, Johannes Lorscheider, Yvonne Naegelin

Abstract

Background: There is an unmet need for reliable and sensitive measures for better monitoring people with multiple sclerosis (PwMS) to detect disease progression early and adapt therapeutic measures accordingly.

Objective: To assess reliability of extracted features and meaningfulness of 11 tests applied through a smartphone application ("dreaMS").

Methods: PwMS (age 18-70 and EDSS ≤ 6.5) and matched healthy volunteers (HV) were asked to perform tests installed on their smartphone once or twice weekly for 5 weeks. Primary outcomes were test-retest reliability of test features (target: intraclass correlation [ICC] ≥ 0.6 or median coefficient of variation [mCV] < 0.2) and reported meaningfulness of the tests by PwMS. Meaningfulness was self-assessed for each test on a 5-point Likert scale (target: mean score of > 3) and by a structured interview.

Clinicaltrials: gov Identifier: NCT04413032.

Results: We included 31 PwMS (21 [68%] female, mean age 43.4 ± 12.0 years, median EDSS 3.0 [range 1.0-6.0]) and 31 age- and sex-matched healthy volunteers. Out of 133 features extracted from 11 tests, 89 met the preset reliability criteria. All 11 tests were perceived as highly meaningful to PwMS.

Conclusion: The dreaMS app reliably assessed features reflecting key functional domains meaningful to PwMS. More studies with longer follow-up are needed to prove validity of these measures as digital biomarkers in PwMS.

Keywords: Digital biomarkers; Mobile health; Multiple sclerosis; Smartphone; Smartwatch.

Conflict of interest statement

The research activities of Tim Woelfle’s institution, RC2NB (Research Center for Clinical Neuroimmunology and Neuroscience Basel), are supported by the University Hospital and the University of Basel and by grants from Novartis and Roche. One of the main projects of RC2NB is the development of a new comprehensive MS Digital solution. Silvan Pless has nothing to disclose. Oscar Reyes is Senior Data Scientist of Healios AG. Andrea Wiencierz has nothing to disclose. Anthony Feinstein has nothing to disclose. Pasquale Calabrese has received honoraria for speaking at scientific meetings, serving at scientific advisory boards and consulting activities from: Abbvie, Actelion, Almirall, Bayer-Schering, Biogen Idec, Celgene, EISAI, Genzyme, Lundbeck, Merck Serono, Novartis, Pfizer, Teva, and Sanofi-Aventis. His research is also supported by the Swiss Multiple Sclerosis Society and the Swiss National Research Foundation. Konstantin Gugleta has nothing to disclose. Ludwig Kappos has received no personal compensation. His institution (University Hospital Basel/Foundation Clinical Neuroimmunology and Neuroscience Basel) has received the following exclusively for research support: steering committee, advisory board and consultancy fees (Abbvie, Actelion, AurigaVision AG, Biogen, Celgene, Desitin, Eli Lilly, EMD Serono, Genentech, Genzyme, Glaxo Smith Kline, Janssen, Japan Tobacco, Merck, Minoryx, Novartis, Roche, Sanofi, Santhera, Senda, Shionogi, Teva, and Wellmera; speaker fees (Celgene, Janssen, Merck, Novartis, and Roche); support for educational activities (Biogen, Desitin, Novartis, Sanofi and Teva); license fees for Neurostatus products; and grants (European Union, Innosuisse, Novartis, Roche Research Foundation, Swiss MS Society and Swiss National Research Foundation). Johannes Lorscheider’s institution has received research grants from Novartis, Biogen and Innosuisse as well as honoraria for advisory boards and/or speaking fees from Novartis, Roche and Teva. Yvonne Naegelin’s institution (University Hospital Basel) has received financial support for lectures from Teva and Celgene and grant support from Innosuisse (Swiss Innovation Agency). The research activities of RC2NB (Research Center for Clinical Neuroimmunology and Neuroscience Basel) are supported by the University Hospital and the University of Basel and by grants from Novartis and Roche. One of the main projects of RC2NB is the development of a new comprehensive MS Digital solution.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Correlation of top features with clinical reference tests: Spearman ρ (with 95% CI) for top features of (A) movement tests, (B) balance tests (only among PwMS), (C) dexterity tests, (D) m-SDMT, and (E) vision tests

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Source: PubMed

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