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

Hoffmann-La Roche100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

100

Conditions

Multiple Sclerosis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

UCSF- Multiple Sclerosis Centre; Department of Neurology

San Francisco, California, United States

Hospital Vall d'Hebron; Servicio de Neurología

Barcelona, Spain

Outcomes

Primary Outcomes

Compliance Level: Number of Active and Passive Tests Conducted by MS Participants and Healthy Controls in 12 Weeks

Time frame: Week 12

Compliance Level: Number of Active and Passive Tests Conducted by MS Participants and Healthy Controls in 24 Weeks

Time frame: 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

Time frame: 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

Time frame: Week 24