Multiple Sclerosis
Conditions
Keywords
digital monitoring, mHealth, multiple sclerosis
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.
Interventions
DEVICEMS Sherpa
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.
DEVICENeurokeys
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.
Sponsors
Amsterdam UMC, location VUmc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Netherlands
Contacts
Primary ContactDaan de Jong, MD MSc
Backup ContactEva Strijbis, MD PhD
Outcome results
None listed