NCT Number: NCT06627465
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Rijnstate Arnhem, Arnhem, Gelderland, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Since this is an observational cohort study, concomitant participation in any intervention trial is allowed.
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.
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.
Time frame: 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.
Time frame: Throughout the two year follow-up period. Assessments scheduled weekly.
Adherence to the MS sherpa application defined as number of completed from scheduled assessments.
Time frame: Throughout the two year follow-up period. Assessments scheduled weekly.
Outcomes of the MS sherpa application (smartphone SDMT, smartphone 2MWT, patient-reported questionnaire)
Time frame: 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.
Time frame: Daily passive monotring throughout the two year follow-up period.
Adherence to the NeuroKeys application.
Time frame: 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).
Time frame: 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.
Time frame: Continously and daily throughout the two year follow-up period.
Outcomes of the NeuroKeys application (i.e. clusters of keystroke dynamics).
Contact information is provided by the study sponsor or research team.
Daan de Jong, MD MSc
CONTACT
Eva Strijbis, MD PhD
CONTACT
Amsterdam UMC, location VUmc
Other
Acronym: Connect-MS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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