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Coaching and Activity Tracking in Multiple Sclerosis - A Pilot Study (CoachMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03335618
Recruitment Status : Completed
First Posted : November 8, 2017
Last Update Posted : August 20, 2020
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Activity Monitoring and Symptom Coaching Other: Passive Activity Monitoring Not Applicable

Detailed Description:

MS is a chronic, debilitating disease of the central nervous system affecting approximately 2 million people worldwide and more than 400,000 individuals in the US. MS is the most common cause of non-traumatic neurological disability in young adults. Symptoms typically first afflict individuals during the prime of their professional and reproductive lives, between the ages of 20 and 40. Many affected individuals are unemployed, physically disabled, and at high risk for social isolation. While disease-modifying therapies (DMTs) can significantly reduce accumulation of disability in MS, patients still experience symptoms across a range of functional domains. Symptoms can include problems with bladder, walking, and mood (depression and anxiety). Often, these symptoms are only partially evaluated during routine MS clinic visits, and the long interval between clinic visits can result in them not being optimally managed.

The goal of the current study is to pilot a system of proactively monitoring a combination of symptoms (bladder, ambulation and mood) using an activity monitor and a smartphone.

Adult patients with MS who are experiencing symptoms in at least 2 of the 3 domains (bladder, ambulation, mood) will be enrolled. Visits will be at baseline (can be same day as routine visit to the MS clinic), and 3 months. Short surveys (<3 minutes to complete) will occur weekly, and longer surveys will occur at baseline, 6 weeks and 3 months. FitBit activity monitors will be worn for the entire 3 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A First-in-Kind Randomized, Controlled Pilot Clinical Trial Testing Proactive vs Reactive Management of a Symptom Triad in Multiple Sclerosis
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : August 1, 2019
Actual Study Completion Date : March 23, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Active Coaching and Monitoring Other: Activity Monitoring and Symptom Coaching
Triggered check-ins by study personnel to keep participants on track to meet fitness goals

Sham Comparator: Passive Monitoring Other: Passive Activity Monitoring
Passive step tracking without check-ins

Primary Outcome Measures :
  1. Feasibility of an active symptom monitoring and intervention protocol [ Time Frame: 12 weeks ]
    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.

Secondary Outcome Measures :
  1. Improvement in ambulation symptoms in MS participants [ Time Frame: 12 weeks ]
    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.

  2. Improvement in mood symptoms in MS participants. [ Time Frame: 12 weeks ]
    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.

  3. Improvement in bladder symptoms in MS participants. [ Time Frame: 12 weeks ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03335618

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United States, California
University of California, San Francisco
San Francisco, California, United States, 94158
Sponsors and Collaborators
University of California, San Francisco
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Principal Investigator: Riley M Bove, MD University of California, San Francisco
Bove R, Garcha P, Bevan C, et al. Towards a Tele-MSDS: an iterative method to assess the MS patient remotely. ECTRIMS. London 2016.
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.

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Responsible Party: University of California, San Francisco Identifier: NCT03335618    
Other Study ID Numbers: 16-20505
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: August 20, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Additional relevant MeSH terms:
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Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases