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CompletedNCT02845635Updated Apr 20, 2022

MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis

An observational study in Multiple Sclerosis, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-20.

Sponsored by Duke University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
2,200
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Multiple Sclerosis
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 2,200 is above the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
2,200 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

  • 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

  • Control

    This who document during the on-boarding process that they do not suffer from multiple sclerosis.

    Other: Personal history of multiple sclerosis

Interventions

  • OtherPersonal 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.

06

What researchers measure

Primary outcomes

  1. 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

  2. Change in perceived cognitive impairment (self-report) as recorded by symptom diary

    Severity of cognitive impairment experienced from multiple sclerosis

    Time frame: Every 24 hours through study completion, an average of 6 months

  3. Change in perceived depression or anxiety severity (self-report) as recorded by symptom diary

    Severity of any mood disorders experienced from multiple sclerosis

    Time frame: Every 24 hours through study completion, an average of 6 months

Secondary outcomes

  1. Change in perceived walking instability (self-report) as recorded by symptom diary

    Time frame: Every 24 hours through study completion, an average of 6 months

  2. Change in perceived vision difficulties (self-report) as recorded by symptom diary

    Time frame: Every 24 hours through study completion, an average of 6 months

  3. Change in perceived Bowel/Bladder dysfunction (self-report) as recorded by symptom diary

    Severity of bowel/bladder dysfunction experienced from multiple sclerosis

    Time frame: Every 24 hours through study completion, an average of 6 months

  4. Change in perceived sensory disturbance (self-report) as recorded by symptom diary

    Time frame: Every 24 hours through study completion, an average of 6 months

  5. Change in perceived vertigo severity (self-report) as recorded by symptom diary

    Time frame: Every 24 hours through study completion, an average of 6 months

  6. Change in perceived dysarthria severity (self-report) as recorded by symptom diary

    Time frame: Every 24 hours through study completion, an average of 6 months

  7. Change in pain (self-report) as recorded by symptom diary

    Time frame: Every 24 hours through study completion, an average of 6 months

  8. Change in sleep quality as recorded by app-linked wearable device

    Time frame: Every 24 hours through study completion, an average of 6 months

  9. Change in medication adherence (self-report) as recorded by medication diary

    Time frame: Every 24 hours through study completion, an average of 6 months

  10. Change in self-efficacy (self-report) as determined by the Multiple Sclerosis self-efficacy scale (survey instrument)

    Time frame: every three months, through study completion (an average of 6 months)

  11. 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.

    Time frame: prompted based on the app user's responses on the daily surveys, up to 6 months

07

Study locations

1 site
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02845635
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Jul 27, 2016
Start date
Sep 29, 2017
Primary completion
Jul 28, 2021
Completion
Jul 28, 2021
Last update
Apr 20, 2022

Study contacts

Fletcher L Hartsell, MD MPH
principal investigator · Duke University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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