MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02845635
• Other study ID #: Pro00072319
• Status: Completed
• Start date: September 29, 2017
• Est. completion date: July 28, 2021

Study information

• Verified date: April 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2200
• Est. completion date: July 28, 2021
• Est. primary completion date: July 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Be at least 18 years old

• Live in the United States of America

• Read/write in English

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in perceived fatigue severity (self-report) as recorded by symptom diary		Every 24 hours through study completion, an average of 6 months
Primary	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
Primary	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	Change in perceived walking instability (self-report) as recorded by symptom diary		Every 24 hours through study completion, an average of 6 months
Secondary	Change in perceived vision difficulties (self-report) as recorded by symptom diary		Every 24 hours through study completion, an average of 6 months
Secondary	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
Secondary	Change in perceived sensory disturbance (self-report) as recorded by symptom diary		Every 24 hours through study completion, an average of 6 months
Secondary	Change in perceived vertigo severity (self-report) as recorded by symptom diary		Every 24 hours through study completion, an average of 6 months
Secondary	Change in perceived dysarthria severity (self-report) as recorded by symptom diary		Every 24 hours through study completion, an average of 6 months
Secondary	Change in pain (self-report) as recorded by symptom diary		Every 24 hours through study completion, an average of 6 months
Secondary	Change in sleep quality as recorded by app-linked wearable device		Every 24 hours through study completion, an average of 6 months
Secondary	Change in medication adherence (self-report) as recorded by medication diary		Every 24 hours through study completion, an average of 6 months
Secondary	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)
Secondary	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