NCT06125301

Multiple Sclerosis Self Monitoring Study

The Multiple Sclerosis Self Monitoring Study: An Intervention Study on the Effect of Digital Self-monitoring-based Management of Relapsing and Remitting Multiple Sclerosis on Self-efficacy, Clinical Outcomes and Cost-effectiveness

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 225 (estimated)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DEVICE	MS Sherpa	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.

Timeline

• Start date: 2022-08-15
• Primary completion: 2024-08-15
• Completion: 2024-08-15
• First posted: 2023-11-09
• Last updated: 2023-11-09

Locations

1 site across 1 country: Netherlands