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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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). |
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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.
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Patients with multiple sclerosis including the phenotypes RRMS, SPMS and PPMS
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daan de Jong, MD MSc | Contact | +31625716307 | connectms@amsterdamumc.nl | |
| Eva Strijbis, MD PhD | Contact | +31625716307 | connectms@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Joep Killestein, Prof | Amsterdam UMC | Principal Investigator |
| Eva Strijbis, MD PhD | Amsterdam UMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate Arnhem | Arnhem | Gelderland | 6815AD | Netherlands |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| 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. |
| Zuyderland Medical Center | Geleen | Limburg | 6162BG | Netherlands |
|
| Amsterdam UMC | Amsterdam | North Holland | 1081HV | Netherlands |
|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |