NL-OMON54476RecruitingNot Applicable
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 - Multiple sclerosis self-monitoring (MSSM)
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 210
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •1. A minimum age of 18 years.
- •2. Have a definite diagnosis of RRMS according to the revised McDonald 2017
- •3. Have a length of disease duration of >=12 months, from date of MS diagnosis.
- •4. Have clinical disease activity (reported relapses) and/or radiological
- •disease activity (new/enlarged T2 lesions or contrast-enhancing lesions) within
- •the past 12 months.
- •5. 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.
- •6. Willing to stay for treatment with the same hospital during the year of
- •7. 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.
Investigators
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