Validating Digital Biomarkers to Detect Disease Activity and Disease Progression in Multiple Sclerosis (Connect-MS)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: MS Sherpa; Device: Neurokeys

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Daan de Jong, MD MSc; Phone Number: +31625716307; Email: connectms@amsterdamumc.nl
• Study Contact Backup: Name: Eva Strijbis, MD PhD; Phone Number: +31625716307; Email: connectms@amsterdamumc.nl

Study Locations

• Netherlands
  • Gelderland
    • Arnhem, Gelderland, Netherlands, 6815AD
      • Rijnstate Arnhem
      • Contact: Jop Mostert, MD PhD
  • Limburg
    • Geleen, Limburg, Netherlands, 6162BG
      • Zuyderland Medical Center
      • Contact: Oliver Gerlach, MD PhD
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1081HV
      • Amsterdam UMC
      • Contact: Daan de Jong, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with multiple sclerosis including the phenotypes RRMS, SPMS and PPMS

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of digital monitoring questionnaire: healthcare provider	This questionnaire is a self-developed questionniare that focusses on the impact of digital monitoring on clinical consultation and choices during the consult from the perspective of a healthcare provider.	At each clinical consultation throughout the two year study follow-up
Adherence to the MS Sherpa application.	Adherence to the MS sherpa application defined as number of completed from scheduled assessments.	Throughout the two year follow-up period. Assessments scheduled weekly.
Application outcomes of MS Sherpa	Outcomes of the MS sherpa application (smartphone SDMT, smartphone 2MWT, patient-reported questionnaire)	Throughout the two year follow-up period. Assessments scheduled weekly.
Impact of digital monitoring questionnaire: patient	This questionnaire is a self-developed questionniare that focusses on the impact of digital monitoring on clinical consultation and choices during the consult from the perspective of a patient.	At each clinical consultation throughout the two year study follow-up. Standard care is yearly clinical consultation.
Adherence to the Neurokeys application	Adherence to the NeuroKeys application.	Daily passive monotring throughout the two year follow-up period.
Medical consumption questionnaire (iMCQ)	The iMTA Medical Consumption Questionnaire measures the direct healthcare costs in the last three months based on the healthcare consumption (such as hospitalisations, consultations with doctors, use of care at home, use of specialised transportation etc).	At each clinical consultation throughout the two year study follow-up. Standard care is yearly clinical consultation.
Productivity costs questionnaire (iPCQ)	The iMTA Productivity Cost Questionnaire measures the indirect nonmedical costs based on productivity loss by assessing the employment situation and short- and long term sick absence due to MS or MS-related treatment in the last four weeks.	At each clinical consultation throughout the two year study follow-up. Standard care is yearly clinical consultation.
Application outcomes of Neurokeys	Outcomes of the NeuroKeys application (i.e. clusters of keystroke dynamics).	Continously and daily throughout the two year follow-up period.

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc
• Investigators: Principal Investigator: Joep Killestein, Prof, Amsterdam UMC; Principal Investigator: Eva Strijbis, MD PhD, Amsterdam UMC

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: October 2, 2024
• First Posted (Actual): October 4, 2024

Study Record Updates

• Last Update Posted (Actual): October 4, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: multiple sclerosis; mHealth; digital monitoring
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Disease Attributes; Multiple Sclerosis; Sclerosis; Disease Progression
• Other Study ID Numbers: 2024.0188

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No