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

Not yet recruiting

• Conditions: Multiple Sclerosis

• Registration Number: NCT06627465
• Lead Sponsor: Amsterdam UMC, location VUmc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-25
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-02
• Last Update Submitted: 2024-10-02
• Study First Posted: 2024-10-04
• Last Update Posted: 2024-10-04
• Study Start: 2024-10-15
• Primary Completion: 2026-01-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impact of digital monitoring questionnaire: healthcare provider	At each clinical consultation throughout the two year study follow-up	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.
Adherence to the MS Sherpa application.	Throughout the two year follow-up period. Assessments scheduled weekly.	Adherence to the MS sherpa application defined as number of completed from scheduled assessments.
Application outcomes of MS Sherpa	Throughout the two year follow-up period. Assessments scheduled weekly.	Outcomes of the MS sherpa application (smartphone SDMT, smartphone 2MWT, patient-reported questionnaire)
Impact of digital monitoring questionnaire: patient	At each clinical consultation throughout the two year study follow-up. Standard care is yearly clinical consultation.	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.
Adherence to the Neurokeys application	Daily passive monotring throughout the two year follow-up period.	Adherence to the NeuroKeys application.
Medical consumption questionnaire (iMCQ)	At each clinical consultation throughout the two year study follow-up. Standard care is yearly clinical consultation.	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).
Productivity costs questionnaire (iPCQ)	At each clinical consultation throughout the two year study follow-up. Standard care is yearly clinical consultation.	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.
Application outcomes of Neurokeys	Continously and daily throughout the two year follow-up period.	Outcomes of the NeuroKeys application (i.e. clusters of keystroke dynamics).

Trial Locations

Locations (3)

Rijnstate Arnhem; 🇳🇱 Arnhem, Gelderland, Netherlands

Zuyderland Medical Center; 🇳🇱 Geleen, Limburg, Netherlands

Amsterdam UMC; 🇳🇱 Amsterdam, Noord-Holland, Netherlands