NCT05575843Completed
Neurostatus-SMARTCARE in Comparison to Standard Neurostatus-EDSS®
Neurostatus-SMARTCARE in Comparison to Standard Neurostatus- EDSS® - a Swiss Multicenter Randomized Cross-over Study
Source: ClinicalTrials.gov · Last updated 23 Jul 2024
Brief summary (registry, in English)
The Expanded Disability Status Scale (EDSS) is the gold-standard in assessing disability in Multiple Sclerosis (MS). Its current digital form, the Neurostatus-eEDSS®, often serves as primary endpoint in MS clinical trials. The pandemic revealed the need for telemedical alternatives to the in-clinic assessment. Therefore, Neurostatus-SMARTCARE was developed: A trained and certified non-neurologist Health Care Professional (HCP) examines the patient while the examination is being video-recorded. The stored video allows a neurologist to re-assess the examination at a later point of time. The future application could be in-home visits through HCPs, in decentralized clinical trials as well as in routine care. In this study, the concordance rate of Neurostatus examinations between neurologists and HCPs is investigated. With a concordance rate significantly higher than 80%, Neurostatus-SMARTCARE by HCPs can be considered equal to the standard Neurostatus-EDSS by neurologists.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 101 (actual)
- First submitted
- 7 Sept 2022
- Start date
- 9 Dec 2022
- Primary completion date
- 17 Nov 2023
- Lead sponsor
- University Hospital, Basel, Switzerland
- Diseases
- Multiple sclerosis
- NCT number
- NCT05575843
What you commit to
- Study type: Interventional
- Participants enrolled: 101
- From 9 Dec 2022 to the primary completion date, 17 Nov 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Insufficient knowledge of the German language, i.e. inability to understand the patient information or to follow the instructions and questions during the EDSS assessment
Who the study is looking for
- 18 years old at the time of signing the informed consent
- Clinically definite MS, confirmed through the medical chart
- At least one documented EDSS assessment within two (2) years prior to inclusion
- The participant must be capable of giving signed informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Neurologic Clinic and Policlinic, University Hospital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Luzerner Kantonsspital Coordinator of this site? Confirm its status | Lucerne | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.