NL-OMON54476
Recruiting
Not 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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- MS
- Sponsor
- Vrije Universiteit Medisch Centrum
- Enrollment
- 210
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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