MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis

Overview

The purpose of this study is to better characterize the fluctuations in multiple sclerosis symptoms and their relationship to medications, to length/extent of disease, and to a variety of physiologic measures.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 31, 2021

Interventions

  • Other: Personal history of multiple sclerosis
    • Participants will be stratified into one of four cohorts based on their experience (or lack of experience) with the three major forms of multiple sclerosis.

Arms, Groups and Cohorts

  • Relapsing Remitting Multiple Sclerosis
    • Those who document during the study on-boarding process that they suffer from relapsing-remitting multiple sclerosis.
  • Primary Progressive Multiple Sclerosis
    • This who document during the on-boarding process that they suffer from primary progressive multiple sclerosis.
  • Secondary Progressive Multiple Sclerosis
    • This who document during the on-boarding process that they suffer from secondary progressive multiple sclerosis.
  • Control
    • This who document during the on-boarding process that they do not suffer from multiple sclerosis.

Clinical Trial Outcome Measures

Primary Measures

  • Change in perceived fatigue severity (self-report) as recorded by symptom diary
    • Time Frame: Every 24 hours through study completion, an average of 6 months
  • Change in perceived cognitive impairment (self-report) as recorded by symptom diary
    • Time Frame: Every 24 hours through study completion, an average of 6 months
    • Severity of cognitive impairment experienced from multiple sclerosis
  • Change in perceived depression or anxiety severity (self-report) as recorded by symptom diary
    • Time Frame: Every 24 hours through study completion, an average of 6 months
    • Severity of any mood disorders experienced from multiple sclerosis

Secondary Measures

  • Change in perceived walking instability (self-report) as recorded by symptom diary
    • Time Frame: Every 24 hours through study completion, an average of 6 months
  • Change in perceived vision difficulties (self-report) as recorded by symptom diary
    • Time Frame: Every 24 hours through study completion, an average of 6 months
  • Change in perceived Bowel/Bladder dysfunction (self-report) as recorded by symptom diary
    • Time Frame: Every 24 hours through study completion, an average of 6 months
    • Severity of bowel/bladder dysfunction experienced from multiple sclerosis
  • Change in perceived sensory disturbance (self-report) as recorded by symptom diary
    • Time Frame: Every 24 hours through study completion, an average of 6 months
  • Change in perceived vertigo severity (self-report) as recorded by symptom diary
    • Time Frame: Every 24 hours through study completion, an average of 6 months
  • Change in perceived dysarthria severity (self-report) as recorded by symptom diary
    • Time Frame: Every 24 hours through study completion, an average of 6 months
  • Change in pain (self-report) as recorded by symptom diary
    • Time Frame: Every 24 hours through study completion, an average of 6 months
  • Change in sleep quality as recorded by app-linked wearable device
    • Time Frame: Every 24 hours through study completion, an average of 6 months
  • Change in medication adherence (self-report) as recorded by medication diary
    • Time Frame: Every 24 hours through study completion, an average of 6 months
  • Change in self-efficacy (self-report) as determined by the Multiple Sclerosis self-efficacy scale (survey instrument)
    • Time Frame: every three months, through study completion (an average of 6 months)
  • Change in Multiple Sclerosis Quality of Life Inventory
    • Time Frame: prompted based on the app user’s responses on the daily surveys, up to 6 months
    • The Multiple Sclerosis Quality of Life Inventory surveys are prompted based on the app user’s responses on the daily surveys.

Participating in This Clinical Trial

Inclusion Criteria

  • Be at least 18 years old – Live in the United States of America – Read/write in English Exclusion Criteria:

  • None

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Duke University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Fletcher L Hartsell, MD MPH, Principal Investigator, Duke University

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