NCT02845635

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 29, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2021

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

3.8 years

First QC Date

July 14, 2016

Last Update Submit

April 13, 2022

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

  • Change in perceived fatigue severity (self-report) as recorded by symptom diary

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

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

    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

    Severity of any mood disorders experienced from multiple sclerosis

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

Secondary Outcomes (11)

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

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

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

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

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

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

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

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

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

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

  • +6 more secondary outcomes

Study Arms (4)

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

Personal history of multiple sclerosisOTHER

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.

ControlPrimary Progressive Multiple SclerosisRelapsing Remitting Multiple SclerosisSecondary Progressive Multiple Sclerosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Fletcher L Hartsell, MD MPH

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2016

First Posted

July 27, 2016

Study Start

September 29, 2017

Primary Completion

July 28, 2021

Study Completion

July 28, 2021

Last Updated

April 20, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)