Multiple SclerosisNCT02845635
MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Personal history of multiple sclerosis
- How many people
- 2,200 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2017to 28 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study subjects will be self-selecting from the national release of a mobile application.
Who may be able to join
- Be at least 18 years old
- Live in the United States of America
- Read/write in English
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Personal history of multiple sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Relapsing Remitting Multiple Sclerosis | Those who document during the study on-boarding process that they suffer from relapsing-remitting multiple sclerosis. Receives: 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. Receives: 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. Receives: Other: Personal history of multiple sclerosis | |
| Control | This who document during the on-boarding process that they do not suffer from multiple sclerosis. Receives: Other: Personal history of multiple sclerosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in perceived fatigue severity (self-report) as recorded by symptom diary
Measured: 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
Measured: 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
Measured: 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
Measured: Every 24 hours through study completion, an average of 6 months
Change in perceived vision difficulties (self-report) as recorded by symptom diary
Measured: Every 24 hours through study completion, an average of 6 months
Change in perceived Bowel/Bladder dysfunction (self-report) as recorded by symptom diary
Severity of bowel/bladder dysfunction experienced from multiple sclerosis
Measured: Every 24 hours through study completion, an average of 6 months
Change in perceived sensory disturbance (self-report) as recorded by symptom diary
Measured: Every 24 hours through study completion, an average of 6 months
Change in perceived vertigo severity (self-report) as recorded by symptom diary
Measured: Every 24 hours through study completion, an average of 6 months
Change in perceived dysarthria severity (self-report) as recorded by symptom diary
Measured: Every 24 hours through study completion, an average of 6 months
Change in pain (self-report) as recorded by symptom diary
Measured: Every 24 hours through study completion, an average of 6 months
Change in sleep quality as recorded by app-linked wearable device
Measured: Every 24 hours through study completion, an average of 6 months
Change in medication adherence (self-report) as recorded by medication diary
Measured: 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)
Measured: every three months, through study completion (an average of 6 months)
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.
Measured: prompted based on the app user's responses on the daily surveys, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study start29 Sep 2017
- Primary completion28 Jul 2021
- Study completion28 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fletcher L Hartsell, MD MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845635
- Sponsor's protocol ID
- Pro00072319
- Status last verified
- Apr 2022
- First submitted
- 14 Jul 2016
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02845635
- Acronym / sponsor ID
- Pro00072319
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,200 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 28 Jul 2021 (actual)
- Study completion
- 28 Jul 2021 (actual)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Relapsing Remitting Multiple Sclerosis | – | Other: Personal history of multiple sclerosisThose who document during the study on-boarding process that they suffer from relapsing-remitting multiple sclerosis. |
| Primary Progressive Multiple Sclerosis | – | Other: Personal history of multiple sclerosisThis who document during the on-boarding process that they suffer from primary progressive multiple sclerosis. |
| Secondary Progressive Multiple Sclerosis | – | Other: Personal history of multiple sclerosisThis who document during the on-boarding process that they suffer from secondary progressive multiple sclerosis. |
| Control | – | Other: Personal history of multiple sclerosisThis who document during the on-boarding process that they do not suffer from multiple sclerosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study subjects will be self-selecting from the national release of a mobile application.
Key inclusion criteria (3 listed)
- Be at least 18 years old
- Live in the United States of America
- Read/write in English
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personal history of multiple sclerosisParticipants will be stratified into one of four cohorts based on their experience (or lack of experience) with the three major forms of multiple sclerosis. | Other | Control, Primary Progressive Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis |
Primary outcome
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
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
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
11 secondary outcomes
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
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
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
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
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
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
Change in pain (self-report) as recorded by symptom diary
Time frame: 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
Change in medication adherence (self-report) as recorded by medication diary
Time frame: 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)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fletcher L Hartsell, MD MPH principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.