Multiple Sclerosis Self Monitoring Study (MSSM)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: MS Sherpa

• Study Type: Interventional
• Enrollment (Estimated): 225
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • Amsterdam UMC, locatie VUmc
    • Contact: Pam Molenaar, MD; Phone Number: +31625716307; Email: p.c.g.molenaar@amsterdamumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Signed informed consent form.
2. Able to comply with the study protocol, as judged by the investigator.
3. A minimum age of 18 years.
4. Have a definite diagnosis of RRMS according to the revised McDonald 2017 criteria.
5. Have a length of disease duration of ≥12 months, from date of MS diagnosis.
6. Have clinical disease activity (one or more reported relapses) and/or radiological disease activity (new/enlarged T2 lesions or T1 contrast-enhancing lesions) within the past 12 months.
7. Willing and able to install and use MS sherpa® on own smartphone with Android (version 4.4 or higher) or iOS (version 9 or higher) operating system.
8. Willing to stay for treatment with the same hospital during the year of study.
9. Willing to follow the rules of conduct as described in Appendix A during the year of study.

Exclusion Criteria:

1. EDSS of > 6.5 at baseline screening.
2. Presence of a cognitive, visual or upper extremity deficit that disables the use or measurements of MS sherpa® on the smartphone, as judged by the investigator.
3. Concomitant use of health monitoring apps or devices for MS during the study.
4. Concomitant participation in another intervention trial in MS.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Care as usual.
Experimental: Intervention group; Care as usual + weekly self-monitoring during one year follow-up and discussing app results with caregivers.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Estimated): August 15, 2024
• Study Completion (Estimated): August 15, 2024

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: November 4, 2023
• First Posted (Actual): November 9, 2023

Study Record Updates

• Last Update Posted (Actual): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 4, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: NL75687.029.20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No