MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis

April 13, 2022 updated by: Duke University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
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
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.
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
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.
Control
This who document during the on-boarding process that they do not suffer from multiple sclerosis.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
Every 24 hours through study completion, an average of 6 months
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
Every 24 hours through study completion, an average of 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Every 24 hours through study completion, an average of 6 months
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
Every 24 hours through study completion, an average of 6 months
Change in perceived Bowel/Bladder dysfunction (self-report) as recorded by symptom diary
Time Frame: Every 24 hours through study completion, an average of 6 months
Severity of bowel/bladder dysfunction experienced from multiple sclerosis
Every 24 hours through study completion, an average of 6 months
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
Every 24 hours through study completion, an average of 6 months
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
Every 24 hours through study completion, an average of 6 months
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
Every 24 hours through study completion, an average of 6 months
Change in pain (self-report) as recorded by symptom diary
Time Frame: Every 24 hours through study completion, an average of 6 months
Every 24 hours through study completion, an average of 6 months
Change in sleep quality as recorded by app-linked wearable device
Time Frame: Every 24 hours through study completion, an average of 6 months
Every 24 hours through study completion, an average of 6 months
Change in medication adherence (self-report) as recorded by medication diary
Time Frame: Every 24 hours through study completion, an average of 6 months
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)
Time Frame: every three months, through study completion (an average of 6 months)
every three months, through study completion (an average of 6 months)
Change in Multiple Sclerosis Quality of Life Inventory
Time Frame: 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.
prompted based on the app user's responses on the daily surveys, up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fletcher L Hartsell, MD MPH, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 28, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00072319

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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