MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis

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 Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Personal history of multiple sclerosis

• Study Type: Observational
• Enrollment (Actual): 2200

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study subjects will be self-selecting from the national release of a mobile application.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Fletcher L Hartsell, MD MPH, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2017
• Primary Completion (Actual): July 28, 2021
• Study Completion (Actual): July 28, 2021

Study Registration Dates

• First Submitted: July 14, 2016
• First Submitted That Met QC Criteria: July 22, 2016
• First Posted (Estimate): July 27, 2016

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: Pro00072319

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO