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

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Device: Smartphone and Smartwatch

• Registration Number: NCT02952911
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-11-01
• Study First Submitted QC: 2016-11-01
• Study First Posted: 2016-11-02
• Study Start: 2016-11-28
• Primary Completion: 2018-05-04
• Study Completion: 2018-05-04
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-21
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A: MS Participants	Smartphone and Smartwatch	MS participants will perform various active tests (daily, weekly or bi-weekly) and passive monitoring (daily) using smartphone and smartwatch over 24 weeks.
B: Healthy Controls	Smartphone and Smartwatch	Healthy participants will perform various active tests (daily, weekly or bi-weekly) and passive monitoring (daily) using smartphone and smartwatch over 24 weeks.

Primary Outcome Measures

Name	Time	Method
Compliance Level: Number of Active and Passive Tests Conducted by MS Participants and Healthy Controls in 24 Weeks	Week 24
Compliance Level: Number of Active and Passive Tests Conducted by MS Participants and Healthy Controls in 12 Weeks	Week 12
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

Trial Locations

Locations (2)

Hospital Vall d'Hebron; Servicio de Neurología; 🇪🇸 Barcelona, Spain

UCSF- Multiple Sclerosis Centre; Department of Neurology; 🇺🇸 San Francisco, California, United States