Clinical trial NCT05575843: Neurostatus-SMARTCARE in Comparison to Standard Neurostatus-EDSS®
Official title: Neurostatus-SMARTCARE in Comparison to Standard Neurostatus- EDSS® - a Swiss Multicenter Randomized Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis (MS)
Keywords: Expanded Disability Status Scale (EDSS)
Neurostatus
Neurostatus-eEDSS
Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Novartis Pharma AG, Basel, Switzerland
First posted: 2022-10-12
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Multicentre randomized cross-over study: Randomization 1:1 to group A and group B. Group A undergoes first the Neurostatus-EDSS® and afterwards the Neurostatus-SMARTCARE. Group B starts with the Neurostatus-SMARTCARE and finishes with the Neurostatus-EDSS®. At the next visit the reverse order is applied, by the same neurologist and HCP.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: In MS, a specific form of the neurological assessment is the gold-standard to evaluate patients' clinical activity and the evolvement of disability over time: the EDSS. The scale was introduced in 1983 by Kurtzke and has been developed further to the "Neurostatus" by Kappos and co-workers for better reproducibility. In 2011 a digital format of the Neurostatus-EDSS was implemented, the Neurostatus-eEDSS®. It often serves as primary endpoint in MS clinical trials.

Neurostatus-eEDSS® organizes the neurological examination into 8 chapters, which are: visual functional system (FS), brainstem FS, pyramidal FS, cerebellar FS, sensory FS, bowel and bladder FS, cerebral FS and ambulation score. The eight chapters are in turn composed of individual elements (subscores) that investigate neurological functions. Thus, the Neurostatus-eEDSS® results in a total of 121 subcores which are synthetized into 7 FS scores and an ambulation score. The result of the 7 FS scores plus the ambulation score is the EDSS step. The best EDSS step score - 0 (zero) - identifies a normal neurologic examination, and the worst score - 10 (ten) - stands for death due to MS. In-between are intervals of 0.5 steps.

The pandemic revealed the need for telemedical alternatives when as well clinical visits as study visits couldn't be continued routinely. Therefore, the Neurostatus-SMARTCARE was developed: A trained and certified non-neurologist Health Care Professional performs the EDSS examination with the patient while the examination is being video-recorded. The stored video allows a neurologist at a later time-point to review and re-assess the examination and to establish his/ her diagnostic and therapeutic evaluations on it. If the complementary Neurostatus-form "SMARTCARE (smartly modernized assessment - recorded, telemedical, care professional-assisted, remotely evaluated)" was equal to the standard Neurostatus-EDSS, it could be applied at patients' homes in decentralized clinical trials or telemedical clinical consultations.

In this study the Neurostatus-SMARTCARE, performed by trained HCPs is compared to the standard Neurostatus-EDSS, performed by neurologists.

At two routine clinical visits a neurologist and a nurse perform the EDSS one after the other with a break for the patient as needed. To account for potential sequence effects, the order of assessment is randomly assigned to "first neurologist, then nurse" (group A) and "first nurse, then neurologist" (group B). At the next clinical consultation (visit 2), the reverse order is applied. All assessments are video-recorded.

Each pair of assessment is compared with regard to concordance as to the 3 levels of the scale: EDSS step, Functional System Scores (FSS) and subscores. Comparison is automated in a digital tool. In case of discrepancies, an EDSS expert assesses the videos to determine, which is the correct examination result.

The neurologists and nurses are blinded to each others' assessment results and to the participants' previous EDSS step. The experts are blinded to the raters' identity until the moment of watching a video.

Eligibility 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

Primary outcomes:
measure: Inter-rater reliability, i.e. the concordance rate between Neurostatus-SMARTCARE and Neurostatus-EDSS® at EDSS step level
timeFrame: 1.5 - 2 hours per study visit for each participant
Secondary outcomes:
measure: Inter-rater reliability at subscore level between Neurostatus-SMARTCARE and standard Neurostatus-EDSS®
timeFrame: 1.5 - 2 hours per study visit for each participant
measure: Inter-rater reliability at Functional System Score (FSS) levels between Neurostatus-SMARTCARE and standard Neurostatus-EDSS®
timeFrame: 1.5 - 2 hours per study visit for each participant
measure: Number of assessments rated correctly by neurologists in comparison to HCPs
timeFrame: Through study completion, an average of 1.5 years
measure: Number and type of the same error occurring more than once at the individual rater level
timeFrame: Through study completion, an average of 1.5 years
measure: 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.
timeFrame: Through study completion, an average of 1.5 years
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Neurologic Clinic and Policlinic, University Hospital Basel
city: Luzern 16
country: Switzerland
facility: Luzerner Kantonsspital
Study officials:
affiliation: Foundation Clinical Neuroimmunology and Neuroscience Basel (RC2NB)
name: Ludwig Kappos, Prof. Dr. med. Dr. h. c. mult.
role: STUDY_DIRECTOR
References: