Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT03335618
Status:
COMPLETED
Last Update Posted:
2020-08-20
First Post:
2017-10-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Coaching and Activity Tracking in Multiple Sclerosis - A Pilot Study
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
A First-in-Kind Randomized, Controlled Pilot Clinical Trial Testing Proactive vs Reactive Management of a Symptom Triad in Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CoachMS
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: