Neurostatus-SMARTCARE in Comparison to Standard Neurostatus-EDSS®

NCT05575843 | Completed

• 1 other identifier: 2022-01294; ko22DSouza
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Sclerosis (MS)

Keywords

Expanded Disability Status Scale (EDSS); Neurostatus; Neurostatus-eEDSS; Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB)

Outcome Measures

Primary Outcomes (1)

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

  The pairwise concordance among all EDSS-steps between a neurologist's and a nurse's assessment of the the same participant at one visit will be tested and an overall concordance rate of all EDSS-steps. The true concordance level needs to be at least 89% to have a reasonable chance of demonstrating that the observed rate is significantly higher than 80%. If this can be shown, it can be concluded that Neurostatus-SMARTCARE is equivalent to the standardized Neurostatus-EDSS in clinical routine or clinical trials. This would allow HCPs to assess the Neurostatus-EDSS with the same quality as neurologists.

  1.5 - 2 hours per study visit for each participant

Secondary Outcomes (5)

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

  1.5 - 2 hours per study visit for each participant

• 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

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

  Through study completion, an average of 1.5 years

• 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

• 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

Study Arms (2)

Group A

OTHER

First neurologist, second nurse

Other: Neurostatus-SMARTCARE; Other: Standard Neurostatus-EDSS

Group B

OTHER

First nurse, second neurologist

Other: Neurostatus-SMARTCARE; Other: Standard Neurostatus-EDSS

Interventions

Neurostatus-SMARTCARE OTHER

The Neurostatus-EDSS is assessed by HCPs while the examination is video-recorded. HCPs underwent extended training. For details of the examination refer to the second section of the detailed description.

Group A; Group B

Standard Neurostatus-EDSS OTHER

The Neurostatus-EDSS is assessed by neurologists while the examination is video-recorded. Neurologists underwent standard training.

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old at the time of signing the informed consent
• Clinically definite MS, confirmed through the medical chart
• The participant must be capable of giving signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Novartis Pharma AG, Basel, Switzerland: collaborator

Study Sites (2)

Neurologic Clinic and Policlinic, University Hospital Basel

Basel, 4031, Switzerland

Location

Luzerner Kantonsspital

Lucerne, 6000, Switzerland

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ludwig Kappos, Prof. Dr. med. Dr. h. c. mult.

  Foundation Clinical Neuroimmunology and Neuroscience Basel (RC2NB)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The HCPs and neurologists performing the examinations are blinded to each others' assessment scores and to the results of previous clinical EDSS examinations. The evaluating experts are blinded to the raters' identity until watching an examination video.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: October 12, 2022
• Study Start: December 9, 2022
• Primary Completion: November 17, 2023
• Study Completion: March 1, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

CH (2)