MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Personal history of multiple sclerosis

• Registration Number: NCT02845635
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-14
• Study First Submitted QC: 2016-07-22
• Study First Posted: 2016-07-27
• Study Start: 2017-09-29
• Primary Completion: 2021-07-28
• Study Completion: 2021-07-28
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-13
• Last Update Posted: 2022-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2200

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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	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	Every 24 hours through study completion, an average of 6 months	Severity of any mood disorders experienced from multiple sclerosis

Secondary Outcome Measures

Name	Time	Method
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	Severity of bowel/bladder dysfunction experienced from multiple sclerosis
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	The Multiple Sclerosis Quality of Life Inventory surveys are prompted based on the app user's responses on the daily surveys.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States