MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis

Duke University1 site in 1 country2,200 target enrollmentSeptember 29, 2017

ConditionsMultiple Sclerosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Multiple Sclerosis
Sponsor: Duke University
Enrollment: 2200
Locations: 1
Primary Endpoint: Change in perceived fatigue severity (self-report) as recorded by symptom diary
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 29, 2017

End Date

July 28, 2021

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Duke University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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 Outcomes

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(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(prompted based on the app user's responses on the daily surveys, up to 6 months)