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Trial record 2 of 2148 for:    MULTIPLE SCLEROSIS

MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT02845635
Recruitment Status : Recruiting
First Posted : July 27, 2016
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Multiple Sclerosis Other: Personal history of multiple sclerosis

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis
Actual Study Start Date : September 29, 2017
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : August 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  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 [ Time Frame: Every 24 hours through study completion, an average of 6 months ]
    Severity of cognitive impairment experienced from multiple sclerosis

  3. 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


Secondary Outcome Measures :
  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 [ Time Frame: Every 24 hours through study completion, an average of 6 months ]
    Severity of bowel/bladder dysfunction experienced from multiple sclerosis

  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 [ 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02845635


Contacts
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Contact: Fletcher L Hartsell, MD MPH 919-684-8615 lee.hartsell@duke.edu
Contact: Katherine Heller, PhD 919-684-3437 katherine.heller@duke.edu

Locations
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United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Fletcher L Hartsell, MD MPH    919-684-8615    lee.hartsell@duke.edu   
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Fletcher L Hartsell, MD MPH Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02845635     History of Changes
Other Study ID Numbers: Pro00072319
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases