Clinical trial NCT06627465: Validating Digital Biomarkers to Detect Disease Activity and Disease Progression in Multiple Sclerosis
Official title: Validating Digital Biomarkers to Detect Disease Activity and Disease Progression in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Multiple Sclerosis
Keywords: digital monitoring
mHealth
multiple sclerosis
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with multiple sclerosis including the phenotypes RRMS, SPMS and PPMS

Brief summary: The Connect-MS is multicentre real-world observational cohort study wherin the outcomes of standard care digital monitoring of 700 patients with multiple sclerosis (including all subtypes) are recorded over a follow-up period of two years. Patients use the MS sherpa and NeuroKeys applications. Outcomes are related to the utilisation of digital biomarkers including the adherence to digital monitoring and the impact digital outcomes have on clinical decision making, the effect of digital monitoring on healthcare consumption, and the ability of these technological biomarkers to detect clinical outcomes on the short and long term. Most recorded variables are part of the standard care, however participants of this study are also subject to additional questionnaires regarding the consumption of healthcare and the influence of digital monitoring on decision making during clinical consultation.


Eligibility criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria:

* Have signed non-WMO informed consent
* Be able to comply with the study protocol, as judged by the investigator.
* Have a minimum age of 18 years.
* Have a definite diagnosis multiple sclerosis (either RRMS, SPMS or PPMS) according to the revised 2017 McDonald criteria. (Thompson et al., 2018)
* Willing and able to install and use MS Sherpa and NeuroKeys on a privately-owned cell phone.

Since this is an observational cohort study, concomitant participation in any intervention trial is allowed.

Primary outcomes:
measure: Impact of digital monitoring questionnaire: healthcare provider
timeFrame: At each clinical consultation throughout the two year study follow-up
measure: Adherence to the MS Sherpa application.
timeFrame: Throughout the two year follow-up period. Assessments scheduled weekly.
measure: Application outcomes of MS Sherpa
timeFrame: Throughout the two year follow-up period. Assessments scheduled weekly.
measure: Impact of digital monitoring questionnaire: patient
timeFrame: At each clinical consultation throughout the two year study follow-up. Standard care is yearly clinical consultation.
measure: Adherence to the Neurokeys application
timeFrame: Daily passive monotring throughout the two year follow-up period.
measure: Medical consumption questionnaire (iMCQ)
timeFrame: At each clinical consultation throughout the two year study follow-up. Standard care is yearly clinical consultation.
measure: Productivity costs questionnaire (iPCQ)
timeFrame: At each clinical consultation throughout the two year study follow-up. Standard care is yearly clinical consultation.
measure: Application outcomes of Neurokeys
timeFrame: Continously and daily throughout the two year follow-up period.
Secondary outcomes:
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Arnhem
state: Gelderland
city: Geleen
country: Netherlands
facility: Zuyderland Medical Center
state: Limburg
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord-Holland
Study officials:
affiliation: Amsterdam UMC
name: Joep Killestein, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam UMC
name: Eva Strijbis, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: