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This study is a multicenter, prospective, randomized controlled trial (RCT) to compare the effectiveness of a smartphone-based self-monitoring and self-management tool on control self-efficacy with respect to standard clinical practice for patients with relapsing-remitting multiple sclerosis (RRMS). RRMS patients will be recruited and screened for study eligibility at four Dutch MS centers. Following inclusion, participants will be randomly allocated to the intervention group (use of MS sherpa® in addition to standard care) or control group (standard care only). The duration of follow-up is 12 months with study visits at baseline and 12 months, and additional study assessments coupled with every clinical visit as part of standard care during the follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Care as usual + weekly self-monitoring during one year follow-up and discussing app results with caregivers. |
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| Control group | No Intervention | Care as usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MS Sherpa | Device | MS sherpa® is a medical device, intended to support monitoring of persons with MS in order to give patients and their professional healthcare team(s) insight into the presence and progress of symptoms related to MS. MS sherpa® is a system consisting of a smartphone app for data collection and data presentation, a cloud service for data storage, analysis algorithms, and a clinician or research dashboard for user management and data visualization. The device measures the course of symptoms related to MS with respect to walking speed (average walking speed derived from the distance walked during a 2-minute walk), cognitive processing speed, number of correct answers on a smartphone variant of the symbol digit modalities test (SDMT) and patient reported outcomes, through predefined questionnaires regarding fatigue, amongst others. MS sherpa® measures changes in these parameters over time and shows these on an insights screen in the app and on the clinician dashboard. |
| Measure | Description | Time Frame |
|---|---|---|
| the Multiple Sclerosis Self-Efficacy Control scale (MSSE-C) | the MS Self-Efficacy scale is an 18-item scale assessing self-rated certainty regarding specific behaviours related to functional independence and psychological management of MS. Items are rated on a scale from 10 (very uncertain) to 100 (very certain). The MSSE consist of two subscales by summing the respective items: SE Function, and SE Control. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Decision making process - caregiver | Provider Decision Process Assessment Instrument (PDPAI) for neurologists, adapted with an additional five questions about the use of MS sherpa® in the decision-making process. | One year |
| Decision making process - patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC, locatie VUmc | Recruiting | Amsterdam | 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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|
Decisional Conflict Scale (DCS) for persons with MS, adapted with an additional five questions about the use of MS sherpa® in the decision-making process. |
| One year |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |