Monitoring of Multiple Sclerosis (MS) Participants With the Use of Digital Technology (Smartphones and Smartwatches) - A Feasibility Study

Conditions

Multiple Sclerosis

Brief summary

This prospective pilot study will assess the feasibility of remote participant monitoring using digital technology in participants with MS and healthy controls. At the enrollment visit, the participants as well as the healthy controls will be provided with a remote patient monitoring solution which includes preconfigured smartphone and smartwatch. The configured smartphone and smartwatch pair will contain application software that prompts the user to perform various assessments, referred to as active tests and passive monitoring. Active tests will include Hand Motor Function Test (HMFT), gait test, static balance test, electronic version of the Symbol Digit Modalities Test (eSDMT), Mood Scale Question (MSQ), MS Impact Scale (29-item scale) (MSIS-29) questionnaire, MS Symptom Tracking (MSST). Passive monitoring will be done to collect metrics on gait and mobility throughout the daily life of participants in a continuous and unobtrusive manner.

Jennifer Graves, Marcin Elantkowski, Yanping Zhang, Frank Dondelinger, Florian Lipsmeier et al. (9 authors)

JMIR Formative Research2023-10-0213 citations

10.2196/46521

Neural correlates of digital measures shown by structural MRI: a post-hoc analysis of a smartphone-based remote assessment feasibility study in multiple sclerosis.

Ganzetti M, Graves JS, Holm SP, Dondelinger F, Midaglia L, Gaetano L, Craveiro L, Lipsmeier F, Bernasconi C, Montalban X, Hauser SL, Lindemann M.

2022-12-0510 citations

10.1007/s00415-022-11494-0

A smartphone sensor-based digital outcome assessment of multiple sclerosis

Xavier Montalbán, Jennifer Graves, Luciana Midaglia, Patricia Mulero, Laura Julián et al. (16 authors)

Multiple Sclerosis Journal2021-07-14103 citations

10.1177/13524585211028561

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

Luciana Midaglia, Patricia Mulero, Xavier Montalbán, Jennifer Graves, Stephen L. Hauser et al. (15 authors)

Journal of Medical Internet Research2019-08-30129 citations

10.2196/14863

FLOODLIGHT: Smartphone-Based Self-Monitoring Is Accepted by Patients and Provides Meaningful, Continuous Digital Outcomes Augmenting Conventional In-Clinic Multiple Sclerosis Measures (P3.2-024)

Xavier Montalbán, Patricia Mulero, Luciana Midaglia, Jennifer Graves, Stephen L. Hauser et al. (14 authors)

Neurology2019-04-093 citations

10.1212/wnl.92.15_supplement.p3.2-024

FLOODLIGHT: Remote Self-Monitoring Is Accepted by Patients and Provides Meaningful, Continuous Sensor-Based Outcomes Consistent With and Augmenting Conventional In-Clinic Measures (P4.382)

Xavier Montalbán, Patricia Mulero, Luciana Midaglia, Jennifer Graves, Stephen L. Hauser et al. (15 authors)

Neurology2018-04-105 citations

10.1212/wnl.90.15_supplement.p4.382

Interventions

DEVICESmartphone and Smartwatch

Multiple sclerosis participants and healthy controls are required to wear the smartwatch; and to carry smartphone preferably in a median position in a belt bag, or alternatively in their pocket as they go about their daily routine.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

For MS Participants: * Definite diagnosis of MS, confirmed as per the revised McDonald 2010 criteria * Expanded Disability Status Scale (EDSS) of 0.0 to 5.5, inclusive For All Participants: * Weight: 45 to 110 kilograms (kg)

Exclusion criteria

For MS Participants: * Severely ill and unstable participants as per investigator's discretion * Change in dosing regimen or switch of Disease Modifying Therapy (DMT) in the last 12 weeks prior to enrollment For All Participants: * Pregnant or lactating, or intending to become pregnant during the study

Design outcomes

Primary

Measure	Time frame
Compliance Level: Number of Active and Passive Tests Conducted by MS Participants and Healthy Controls in 12 Weeks	Week 12
Compliance Level: Number of Active and Passive Tests Conducted by MS Participants and Healthy Controls in 24 Weeks	Week 24
Satisfaction Questionnaire Score at Week 12: Assessment of MS Participants' and Healthy Volunteers' Experience Regarding Smartphone and Smartwatch Use and its Impact on Their Daily Activities	Week 12
Satisfaction Questionnaire Score at Week 24: Assessment of MS Participants' and Healthy Volunteers' Experience Regarding Smartphone and Smartwatch Use and its Impact on Their Daily Activities	Week 24

Countries

Spain, United States

Outcome results

None listed