Multiple Sclerosis Self Monitoring Study

NCT ID: NCT06125301

Last Updated: 2023-11-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-15
• Study Completion Date: 2024-08-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention group

Care as usual + weekly self-monitoring during one year follow-up and discussing app results with caregivers.

Group Type: EXPERIMENTAL

MS Sherpa

Intervention Type: 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.

Control group

Care as usual.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: lead

Responsible Party

Joep Killestein

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Amsterdam UMC, locatie VUmc

Amsterdam, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Facility Contacts

Pam Molenaar, MD

Role: primary

p.c.g.molenaar@amsterdamumc.nl

+31625716307

Other Identifiers

NL75687.029.20

Identifier Type: -

Identifier Source: org_study_id