Coaching and Activity Tracking in Multiple Sclerosis - A Pilot Study
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/19/2019 |
| Start Date: | October 1, 2017 |
| End Date: | May 1, 2019 |
| Contact: | Riley M Bove, MD |
| Email: | riley.bove@ucsf.edu |
| Phone: | (415) 353-2069 |
A First-in-Kind Randomized, Controlled Pilot Clinical Trial Testing Proactive vs Reactive Management of a Symptom Triad in Multiple Sclerosis
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.
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.
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.
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.
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
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