Validating Digital Biomarkers to Detect Disease Activity and Disease Progression in Multiple Sclerosis

NCT06627465 | Not Yet Recruiting

• 1 other identifier: 2024.0188
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 3

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.

Conditions

Multiple Sclerosis

Keywords

digital monitoring; mHealth; multiple sclerosis

Outcome Measures

Primary Outcomes (8)

• 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.

Interventions

MS Sherpa DEVICE

The MS Sherpa application is a CE-certified smartphone application (installed on the mobile phone of the patient) that collects digital biomarkers using tests (\~six minutes/test: self-monitoring questionnaires, smartphone 2-MWT, and a smartphone SDMT) once per week in the home environment of the patient.

Neurokeys DEVICE

The NeuroKeys application is a CE-certified application (installed on the mobile phone of the patient) that passively and continuously monitors keystroke dynamics of everyday typing as a digital biomarker.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (3)

Rijnstate Arnhem

Arnhem, Gelderland, 6815AD, Netherlands

Location

Zuyderland Medical Center

Geleen, Limburg, 6162BG, Netherlands

Location

Amsterdam UMC

Amsterdam, North Holland, 1081HV, Netherlands

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Joep Killestein, Prof

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

• Eva Strijbis, MD PhD

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daan de Jong, MD MSc

CONTACT

+31625716307; connectms@amsterdamumc.nl

Eva Strijbis, MD PhD

CONTACT

+31625716307; connectms@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator, Clinical Professor, Head of the MS Center Amsterdam

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: October 4, 2024
• Study Start: October 15, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: October 4, 2024

Record last verified: 2024-10

Locations

NL (3)