Validation of the BeCare Multiple Sclerosis Assessment App

NCT04288011 | Unknown

• 1 other identifier: 2000023992
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study involves data collection from use of the BeCare Link LLC mobile device app by subjects with Multiple Sclerosis.

Conditions

Multiple Sclerosis

Keywords

MS; mobile app; machine learning; EDSS; BeCare

Outcome Measures

Primary Outcomes (3)

• Clinical EDSS score vs MLA EDSS score comparison

  To assess the efficacy of using a mobile application to perform routine assessments of neurological and physical functioning in subjects with MS by comparing clinically assigned EDSS scores with EDSS scores assigned by a single or multiple artificial intelligence techniques at various timed intervals

  day 1 (initial visit)

• Clinical EDSS score vs MLA EDSS score comparison

  To assess the efficacy of using a mobile application to perform routine assessments of neurological and physical functioning in subjects with MS by comparing clinically assigned EDSS scores with EDSS scores assigned by a single or multiple artificial intelligence techniques at various timed intervals

  90 days after day 1

• Clinical EDSS score vs MLA EDSS score comparison

  To assess the efficacy of using a mobile application to perform routine assessments of neurological and physical functioning in subjects with MS by comparing clinically assigned EDSS scores with EDSS scores assigned by a single or multiple artificial intelligence techniques at various timed intervals

  180 days after day 1

Secondary Outcomes (2)

• Disease Progression Measured by Change in EDSS score

  weekly for 26 weeks

• Development of a novel application to measure change in MS

  18 months

Study Arms (2)

Clinical EDSS

The Kurtzke EDSS, is a clinical rating scale for multiple sclerosis having scores between 0 to 10 that are assigned by a trained clinician. Smaller impairments are assessed at lower scores and disability is assessed at higher scores. It is important to note, however, that despite being denoted on an ordinal scale, each level on the scale is not indicative of an equal change in disability.

MLA EDSS

The Kurtzke EDSS, is a clinical rating scale or multiple sclerosis having scores between 0 to 10 that are assigned by a technique based upon several different Machine Learning Algorithms that are combined to produce a single score

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with mild to moderate Multiple Sclerosis that can use a mobile app and are ambulatory.

You may qualify if:

• A history of Multiple Sclerosis, which will be verified through medical records and will be classified as clinically definite based on revised McDonald criteria
• Between the ages 18-75
• Mild to moderate disability in one or more of the modalities assessed by the BeCare App.
• Ability to provide Informed Consent.

You may not qualify if:

• Subjects at risk of falling
• Subjects with poor vision that cannot read the screen of a mobile phone

Sponsors & Collaborators

• BeCare Link LLC: lead
• Yale University: collaborator

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

Related Publications (3)

• Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M, Fujihara K, Havrdova E, Hutchinson M, Kappos L, Lublin FD, Montalban X, O'Connor P, Sandberg-Wollheim M, Thompson AJ, Waubant E, Weinshenker B, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol. 2011 Feb;69(2):292-302. doi: 10.1002/ana.22366.

  PMID: 21387374 BACKGROUND

• Sebastiao E, Sandroff BM, Learmonth YC, Motl RW. Validity of the Timed Up and Go Test as a Measure of Functional Mobility in Persons With Multiple Sclerosis. Arch Phys Med Rehabil. 2016 Jul;97(7):1072-7. doi: 10.1016/j.apmr.2015.12.031. Epub 2016 Mar 2.

  PMID: 26944709 BACKGROUND

• Berrigan LI, Fisk JD, Walker LA, Wojtowicz M, Rees LM, Freedman MS, Marrie RA. Reliability of regression-based normative data for the oral symbol digit modalities test: an evaluation of demographic influences, construct validity, and impairment classification rates in multiple sclerosis samples. Clin Neuropsychol. 2014;28(2):281-99. doi: 10.1080/13854046.2013.871337. Epub 2014 Jan 20.

  PMID: 24438521 BACKGROUND

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

• Sharon Stoll, DO,MS

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2020
• First Posted: February 27, 2020
• Study Start: February 26, 2021
• Primary Completion: December 20, 2022
• Study Completion: February 20, 2023
• Last Updated: December 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)