Multiple Sclerosis Clinical Trial
— CoachMSOfficial title:
A First-in-Kind Randomized, Controlled Pilot Clinical Trial Testing Proactive vs Reactive Management of a Symptom Triad in Multiple Sclerosis
NCT number | NCT03335618 |
Other study ID # | 16-20505 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 1, 2017 |
Est. completion date | March 23, 2020 |
Verified date | August 2020 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this 12-week, exploratory pilot clinical trial is to continuously and remotely assess a triad of bothersome multiple sclerosis (MS) symptoms (BAM: bladder, ambulation, mood) and test the benefit of proactively treating these symptoms according to an evidence-based, multi-disciplinary, personalized protocol.
Status | Completed |
Enrollment | 30 |
Est. completion date | March 23, 2020 |
Est. primary completion date | August 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Any individual above the age of 18 with a confirmed diagnosis of MS - Access to a smartphone - Access to Wi-Fi at home - Able to walk (including with a cane or walker) - Willing to fill out surveys at multiple time points Exclusion Criteria: - Clinician's assessment of cognitive, dexterity, or visual impairment limiting ability to use a smartphone and subsequent technologies required by the study - Inability to walk |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Block VJ, Lizée A, Crabtree-Hartman E, Bevan CJ, Graves JS, Bove R, Green AJ, Nourbakhsh B, Tremblay M, Gourraud PA, Ng MY, Pletcher MJ, Olgin JE, Marcus GM, Allen DD, Cree BA, Gelfand JM. Continuous daily assessment of multiple sclerosis disability using remote step count monitoring. J Neurol. 2017 Feb;264(2):316-326. doi: 10.1007/s00415-016-8334-6. Epub 2016 Nov 28. — View Citation
Bove R, Garcha P, Bevan C, et al. Towards a Tele-MSDS: an iterative method to assess the MS patient remotely. ECTRIMS. London 2016.
Bove R, White CC, Giovannoni G, Glanz B, Golubchikov V, Hujol J, Jennings C, Langdon D, Lee M, Legedza A, Paskavitz J, Prasad S, Richert J, Robbins A, Roberts S, Weiner H, Ramachandran R, Botfield M, De Jager PL. Evaluating more naturalistic outcome measures: A 1-year smartphone study in multiple sclerosis. Neurol Neuroimmunol Neuroinflamm. 2015 Oct 15;2(6):e162. doi: 10.1212/NXI.0000000000000162. eCollection 2015 Dec. — View Citation
Motl RW, Pilutti L, Sandroff BM, Dlugonski D, Sosnoff JJ, Pula JH. Accelerometry as a measure of walking behavior in multiple sclerosis. Acta Neurol Scand. 2013 Jun;127(6):384-90. doi: 10.1111/ane.12036. Epub 2012 Dec 13. — View Citation
Ritvo PG F, J. S., Miller, D. M., Andrews, H., Paty, D. W., LaRocca, N.G. . Multiple Sclerosis Quality of Life Inventory: A User's Manual. New York: National Multiple Sclerosis Society, 1997.
Schwartz CE, Ayandeh A, Motl RW. Investigating the minimal important difference in ambulation in multiple sclerosis: a disconnect between performance-based and patient-reported outcomes? J Neurol Sci. 2014 Dec 15;347(1-2):268-74. doi: 10.1016/j.jns.2014.10.021. Epub 2014 Oct 18. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of an active symptom monitoring and intervention protocol | To evaluate feasibility of the intervention, we will calculate how many patients remain in the study, levels of patient satisfaction with the monitoring and intervention, and we will analyze patient and provider feedback. | 12 weeks | |
Secondary | Improvement in ambulation symptoms in MS participants | Change in average daily step count according to FitBit step tracking. We will assess the mean observed change of daily steps between both the actively monitored group and the passively monitored group. | 12 weeks | |
Secondary | Improvement in mood symptoms in MS participants. | We will measure changes in the Center of Epidemiologic Studies Depression Scale-Revised (CES-D-R), which is a patient questionnaire that provides a measure of depression. It consists of 20 questions, each of which receives a score between 0 and 3, with higher scores indicating worse depression. The total CESD-R score (0-60) also permits categorization of no, mild, moderate and severe depression. | 12 weeks | |
Secondary | Improvement in bladder symptoms in MS participants. | At the end of the study, we will measure change in the Actionable Bladder Symptom Screening Tool (ABSST), which is a patient-reported scale that identifies patients who could benefit from lower urinary tract assessment and/or possibly treatment. It consists of 8 questions, each graded on 4 points, with higher scores indicating worse bladder function. | 12 weeks |
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