Clinical trial NCT02845635: MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis
Official title: MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study subjects will be self-selecting from the national release of a mobile application.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in perceived fatigue severity (self-report) as recorded by symptom diary
timeFrame: Every 24 hours through study completion, an average of 6 months
measure: Change in perceived cognitive impairment (self-report) as recorded by symptom diary
timeFrame: Every 24 hours through study completion, an average of 6 months
measure: Change in perceived depression or anxiety severity (self-report) as recorded by symptom diary
timeFrame: Every 24 hours through study completion, an average of 6 months
Secondary outcomes:
measure: Change in perceived walking instability (self-report) as recorded by symptom diary
timeFrame: Every 24 hours through study completion, an average of 6 months
measure: Change in perceived vision difficulties (self-report) as recorded by symptom diary
timeFrame: Every 24 hours through study completion, an average of 6 months
measure: Change in perceived Bowel/Bladder dysfunction (self-report) as recorded by symptom diary
timeFrame: Every 24 hours through study completion, an average of 6 months
measure: Change in perceived sensory disturbance (self-report) as recorded by symptom diary
timeFrame: Every 24 hours through study completion, an average of 6 months
measure: Change in perceived vertigo severity (self-report) as recorded by symptom diary
timeFrame: Every 24 hours through study completion, an average of 6 months
measure: Change in perceived dysarthria severity (self-report) as recorded by symptom diary
timeFrame: Every 24 hours through study completion, an average of 6 months
measure: Change in pain (self-report) as recorded by symptom diary
timeFrame: Every 24 hours through study completion, an average of 6 months
measure: Change in sleep quality as recorded by app-linked wearable device
timeFrame: Every 24 hours through study completion, an average of 6 months
measure: Change in medication adherence (self-report) as recorded by medication diary
timeFrame: Every 24 hours through study completion, an average of 6 months
measure: Change in self-efficacy (self-report) as determined by the Multiple Sclerosis self-efficacy scale (survey instrument)
timeFrame: every three months, through study completion (an average of 6 months)
measure: Change in Multiple Sclerosis Quality of Life Inventory
timeFrame: prompted based on the app user's responses on the daily surveys, up to 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Fletcher L Hartsell, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: