ClinicalTrials.gg
CompletedNCT03335618CoachMSUpdated Aug 20, 2020

Coaching and Activity Tracking in Multiple Sclerosis - A Pilot Study

An interventional study of Activity Monitoring and Symptom Coaching and Passive Activity Monitoring in Multiple Sclerosis, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-20.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 20 studies in Multiple Sclerosis by University of California, San Francisco — 6 open to participants now, 10 under way, none of them phase 3. Multiple Sclerosis · University of California, San Francisco.

Enrollment
10th of 15
30 · median 44
Started
2017
with 2 others
No phase
9 of 20
1 open now
Registered
7th of 20
by date

Among the 20 studies in Multiple Sclerosis by University of California, San Francisco, this one is the 10th largest by enrollment of the 15 interventional ones that give a count, is one of 3 that started in 2017, is one of 9 with no phase, and was the 7th registered.

Multiple Sclerosis

3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.

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Open to participants now

6 of the 20 studies in Multiple Sclerosis by University of California, San Francisco are open now, in 1 country. Recruiting first, the newest first:

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By country, each count listing its studies:

All 6 open studies →

Where they have run

Who these studies take

Of the 430 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 211 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Multiple Sclerosis

Keywords

  • Activity
  • Mood
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Active Coaching and Monitoring

    Other: Activity Monitoring and Symptom Coaching

  • Sham comparator
    Passive Monitoring

    Other: Passive Activity Monitoring

Interventions

  • OtherActivity Monitoring and Symptom Coaching

    Triggered check-ins by study personnel to keep participants on track to meet fitness goals

  • OtherPassive Activity Monitoring

    Passive step tracking without check-ins

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks

Secondary outcomes

  1. 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.

    Time frame: 12 weeks

  2. 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.

    Time frame: 12 weeks

  3. 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.

    Time frame: 12 weeks

07

Study locations

1 site
  • University of California, San Francisco
    San Francisco, California 94158, United States
08

References and documents

Publications

  • 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.
  • 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. PubMed 25455299 ↗
  • 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. PubMed 23240822 ↗
  • 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. PubMed 26516627 ↗
  • Block VJ, Lizee 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. PubMed 27896433 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Aug 2019, 22 months.

Of 847 non-industry interventional studies with no phase under Multiple Sclerosis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 43. This study's 22 months is close to that.

Counting every sponsor, half of 869 studies reached it within 21 months; a quarter within 9 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 19, 2017
First posted
Nov 8, 2017
StartActual
Oct 1, 2017
Primary completionActual
Aug 1, 2019
CompletionActual
Mar 23, 2020
Last update
Aug 20, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03335618
Responsible party
Sponsor
First posted
Nov 8, 2017
Start date
Oct 1, 2017
Primary completion
Aug 1, 2019
Completion
Mar 23, 2020
Last update
Aug 20, 2020

Study contacts

Riley M Bove, MD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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