Clinical trial NCT02952911: Monitoring of Multiple Sclerosis (MS) Participants With the Use of Digital Technology (Smartphones and Smartwatches) - A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-11-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Compliance Level: Number of Active and Passive Tests Conducted by MS Participants and Healthy Controls in 12 Weeks
timeFrame: Week 12
measure: Compliance Level: Number of Active and Passive Tests Conducted by MS Participants and Healthy Controls in 24 Weeks
timeFrame: Week 24
measure: 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
timeFrame: Week 12
measure: 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
timeFrame: Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF- Multiple Sclerosis Centre; Department of Neurology
state: California
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron; Servicio de Neurología
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Montalban X, Graves J, Midaglia L, Mulero P, Julian L, Baker M, Schadrack J, Gossens C, Ganzetti M, Scotland A, Lipsmeier F, van Beek J, Bernasconi C, Belachew S, Lindemann M, Hauser SL. A smartphone sensor-based digital outcome assessment of multiple sclerosis. Mult Scler. 2022 Apr;28(4):654-664. doi: 10.1177/13524585211028561. Epub 2021 Jul 14.
citation: Midaglia L, Mulero P, Montalban X, Graves J, Hauser SL, Julian L, Baker M, Schadrack J, Gossens C, Scotland A, Lipsmeier F, van Beek J, Bernasconi C, Belachew S, Lindemann M. Adherence and Satisfaction of Smartphone- and Smartwatch-Based Remote Active Testing and Passive Monitoring in People With Multiple Sclerosis: Nonrandomized Interventional Feasibility Study. J Med Internet Res. 2019 Aug 30;21(8):e14863. doi: 10.2196/14863.