Status:
UNKNOWN
Multiple Sclerosis Self Monitoring Study
Lead Sponsor:
Amsterdam UMC, location VUmc
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 re...
Eligibility Criteria
Inclusion
- Signed informed consent form.
- Able to comply with the study protocol, as judged by the investigator.
- A minimum age of 18 years.
- Have a definite diagnosis of RRMS according to the revised McDonald 2017 criteria.
- Have a length of disease duration of ≥12 months, from date of MS diagnosis.
- 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.
- 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.
- Willing to stay for treatment with the same hospital during the year of study.
- Willing to follow the rules of conduct as described in Appendix A during the year of study.
Exclusion
- EDSS of \> 6.5 at baseline screening.
- 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.
- Concomitant use of health monitoring apps or devices for MS during the study.
- Concomitant participation in another intervention trial in MS.
Key Trial Info
Start Date :
August 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2024
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT06125301
Start Date
August 15 2022
End Date
August 15 2024
Last Update
November 9 2023
Active Locations (1)
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1
Amsterdam UMC, locatie VUmc
Amsterdam, Netherlands