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

Multiple Sclerosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02952911
• Other study ID #: MA30162
• Status: Completed
• Phase: N/A
• Start date: November 28, 2016
• Est. completion date: May 4, 2018

Study information

• Verified date: February 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 4, 2018
• Est. primary completion date: May 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Spain	Hospital Vall d'Hebron; Servicio de Neurología	Barcelona
United States	UCSF- Multiple Sclerosis Centre; Department of Neurology	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance Level: Number of Active and Passive Tests Conducted by MS Participants and Healthy Controls in 12 Weeks		Week 12
Primary	Compliance Level: Number of Active and Passive Tests Conducted by MS Participants and Healthy Controls in 24 Weeks		Week 24
Primary	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
Primary	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