APPS MS: smartphone monitoring in MS
Completed
- Conditions
- Multiple sclerosis (MS)
- Registration Number
- NL-OMON27724
- Lead Sponsor
- VU University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 125
Inclusion Criteria
Age between 18 and 65 years.
- Diagnosis of MS (revised McDonald 2017 criteria).
Exclusion Criteria
- EDSS 7.5 or higher at baseline screening.
- Clinical or radiological disease activity or changes in disease modifying drugs two months prior to baseline screening.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Fatigue: mobile application metrics and clinical outcomes (FSS, Fatigue Severity Scale; CIS20R, Checklist Individual Strength; and MFIS, Modified Fatigue Impact Scale).<br /> <br>- Disease activity: mobile application metrics (NeuroKeys and Mijn Kwik) and clinical outcomes (occurrence of MS relapse, MRI-lesions). <br /><br>- Disease progression: mobile application metrics and clinical outcomes (EDSS, Expanded Disability Status Scale; MSFC, Multiple Sclerosis Functional Composite; BICAMS, Brief International Cognitive Assessment for MS; MRI; OCT, Optical Coherence Tomography).
- Secondary Outcome Measures
Name Time Method - Quality of life (MSIS-29, Multiple Sclerosis Imapct Scale; SF-36, Short Form Health Survey).