NCT06627465Not yet recruiting
Validating Digital Biomarkers to Detect Disease Activity and Disease Progression in Multiple Sclerosis
Source: ClinicalTrials.gov · Last updated 4 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 25 Jun 2024
- Start date
- 15 Oct 2024
- Primary completion date
- 1 Jan 2026
- Lead sponsor
- Amsterdam UMC, location VUmc
- Diseases
- Multiple sclerosis
- NCT number
- NCT06627465
What you commit to
- Study type: Observational
- Planned participants: 600
- From 15 Oct 2024 to the primary completion date, 1 Jan 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Rijnstate Arnhem Coordinator of this site? Confirm its status | Arnhem | Netherlands | Unknown status |
| Zuyderland Medical Center Coordinator of this site? Confirm its status | Geleen | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.