Neurostatus-SMARTCARE in Comparison to Standard Neurostatus-EDSS®

Neurostatus-SMARTCARE in Comparison to Standard Neurostatus- EDSS® - a Swiss Multicenter Randomized Cross-over Study

CompletedNot a drug-phase studyMS (type not specified)NCT05575843

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Neurostatus-SMARTCARE
  • Standard Neurostatus-EDSS

What it measured

Main measures

  • Inter-rater reliability, i.e. the concordance rate between Neurostatus-SMARTCARE and Neurostatus-EDSS® at EDSS step level

    1.5 - 2 hours per study visit for each participant

    Disability progression

Other measures (5)

  • Inter-rater reliability at subscore level between Neurostatus-SMARTCARE and standard Neurostatus-EDSS®

    1.5 - 2 hours per study visit for each participant

    Disability progression

  • Inter-rater reliability at Functional System Score (FSS) levels between Neurostatus-SMARTCARE and standard Neurostatus-EDSS®

    1.5 - 2 hours per study visit for each participant

    Disability progressionFatigue

  • Number of assessments rated correctly by neurologists in comparison to HCPs

    Through study completion, an average of 1.5 years

    Disability progression

  • Number and type of the same error occurring more than once at the individual rater level

    Through study completion, an average of 1.5 years

    Disability progressionFatigue

  • Inter-rater reliability in capturing the number of changes in the Expanded Disability Status Scale (EDSS) through worsening and progression or improvement occurring between the first and second measurement.

    Through study completion, an average of 1.5 years

    Disability progression

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

* 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

Exclusion criteria

* 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Dec 2022

    2. Main results due

      Nov 2023

    3. Finished

      Mar 2024

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