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Completed

NCT Number: NCT02845635

MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Personal history of multiple sclerosis

Other

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 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

    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 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

    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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jul 27, 2016
Registry last updated
Apr 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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