Validation of the BeCare Multiple Sclerosis Assessment App
NCT ID: NCT04288011
Last Updated: 2022-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
30 participants
OBSERVATIONAL
2021-02-26
2023-02-20
Brief Summary
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Detailed Description
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The purpose of the BeCare App is to replicate the clinically-derived EDSS score. Because the app can be used independently by the patients at more frequent intervals, use of the app may lead to earlier detection of a decline in function than would be possible by clinic evaluations; the app would measure function utilizing data that closely parallels the clinically obtained EDSS score. In the clinic it may take up to two years before someone is noted to have progressive features. The implication of using the BeCare MS App is earlier intervention with switching to more effective Disease Modifying Treatment. Further, as the BeCare App has a cognitive assessment component not routinely performed during follow-up clinical visits, the need for earlier intervention may result in more effective therapy and, therefore, slowed disease progression.
The EDSS is scored by first assessing Human Functional systems (FS) scores. These systems include Sensory, Bowel\& Bladder, Cerebral, Ambulation and Visual. Function System Scores correspond to the amount of observed disability in that system. Low scores 0 represent no disability in that system, to a maximum score representing high disability.
Clinicians then assess EDSS scores from these Functional System scores (FS) according to their experience with patients. The EDSS is scored according to the following:
0 Normal neurological exam, no disability in any FS 1.0 No disability, minimal signs in one FS 1.5 No disability, minimal signs in more than one FS 2.0 Minimal disability in one FS 2.5 Mild disability in one FS or minimal disability in two FS 3.0 Moderate disability in one FS, or mild disability in three or four FS. No impairment to walking 3.5 Moderate disability in one FS and more than minimal disability in several others. No impairment to walking 4.0 Significant disability but self-sufficient and up and about some 12 hours a day. Able to walk without aid or rest for 500m 4.5 Significant disability but up and about much of the day, able to work a full day, may otherwise have some limitation of full activity or require minimal assistance. Able to walk without aid or rest for 300m 5.0 Disability severe enough to impair full daily activities and ability to work a full day without special provisions. Able to walk without aid or rest for 200m 5.5 Disability severe enough to preclude full daily activities. Able to walk without aid or rest for 100m 6.0 Requires a walking aid - cane, crutch, etc. - to walk about 100m with or without resting 6.5 Requires two walking aids - pair of canes, crutches, etc. - to walk about 20m without resting 7.0 Unable to walk beyond approximately 5m even with aid. Essentially restricted to wheelchair; though wheels self in standard wheelchair and transfers alone. Up and about in wheelchair some 12 hours a day 7.5 Unable to take more than a few steps. Restricted to wheelchair and may need aid in transferring. Can wheel self but cannot carry on in standard wheelchair for a full day and may require a motorised wheelchair 8.0 Essentially restricted to bed or chair or pushed in wheelchair. May be out of bed itself much of the day. Retains many self-care functions. Generally has effective use of arms 8.5 Essentially restricted to bed much of day. Has some effective use of arms retains some self-care functions 9.0 Confined to bed. Can still communicate and eat 9.5 Confined to bed and totally dependent. Unable to communicate effectively or eat/swallow 10.0 Death due to MS
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Between the ages 18-75
3. Mild to moderate disability in one or more of the modalities assessed by the BeCare App.
4. Ability to provide Informed Consent.
Exclusion Criteria
2. Subjects with poor vision that cannot read the screen of a mobile phone
18 Years
75 Years
ALL
No
Sponsors
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Yale University
OTHER
BeCare Link LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Sharon Stoll, DO,MS
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale University School of Medicine
New Haven, Connecticut, United States
Countries
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References
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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.
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.
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.
Other Identifiers
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2000023992
Identifier Type: -
Identifier Source: org_study_id