Coaching and Activity Tracking in Multiple Sclerosis - A Pilot Study

Study Overview
=================
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.

Official Title
-----------------
A First-in-Kind Randomized, Controlled Pilot Clinical Trial Testing Proactive vs Reactive Management of a Symptom Triad in Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Other: Activity Monitoring and Symptom Coaching
* Other: Passive Activity Monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Coaching and Monitoring<br> | Other: Activity Monitoring and Symptom Coaching<br>* Triggered check-ins by study personnel to keep participants on track to meet fitness goals<br>|
| Sham Comparator: Passive Monitoring<br> | Other: Passive Activity Monitoring<br>* Passive step tracking without check-ins<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Activity, Mood