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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-28

Study Completion Date

2018-05-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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A: MS Participants

MS participants will perform various active tests (daily, weekly or bi-weekly) and passive monitoring (daily) using smartphone and smartwatch over 24 weeks.

Group Type EXPERIMENTAL

Smartphone and Smartwatch

Intervention Type DEVICE

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.

B: Healthy Controls

Healthy participants will perform various active tests (daily, weekly or bi-weekly) and passive monitoring (daily) using smartphone and smartwatch over 24 weeks.

Group Type OTHER

Smartphone and Smartwatch

Intervention Type DEVICE

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.

Interventions

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Smartphone 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes