Smartphone tool for self-monitoring in multiple sclerosis

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 testing if a smartphone app for self-monitoring can help people with relapsing-remitting multiple sclerosis manage their condition better than just regular doctor visits alone.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 225 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Amsterdam UMC, location VUmc (other)
• Locations: 1 site (Amsterdam)
• Trial ID: NCT06125301 on ClinicalTrials.gov

What this trial studies

This multicenter, prospective, randomized controlled trial aims to evaluate the effectiveness of a smartphone-based self-monitoring and self-management tool, MS sherpa®, compared to standard clinical practice for patients with relapsing-remitting multiple sclerosis (RRMS). Participants will be recruited from four Dutch MS centers and randomly assigned to either the intervention group, which will use the MS sherpa® app alongside standard care, or the control group, which will receive standard care only. The study will follow participants for 12 months, with assessments at baseline and at the end of the follow-up period, as well as additional evaluations during routine clinical visits.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of relapsing-remitting multiple sclerosis and recent clinical or radiological disease activity.

Not a fit: Patients with significant disabilities or cognitive impairments that prevent the use of a smartphone may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance self-efficacy and disease management for patients with multiple sclerosis.

How similar studies have performed: While similar smartphone-based interventions have shown promise in other conditions, this specific approach for RRMS is relatively novel.

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.

Where this trial is running

Amsterdam

• Amsterdam UMC, locatie VUmc — Amsterdam, Netherlands (RECRUITING)

Conditions: Multiple Sclerosis