Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-02-21 @ 10:34 AM
Study NCT ID:
NCT02845635
Status:
COMPLETED
Last Update Posted:
2022-04-20
First Post:
2016-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-13', 'studyFirstSubmitDate': '2016-07-14', 'studyFirstSubmitQcDate': '2016-07-22', 'lastUpdatePostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in perceived fatigue severity (self-report) as recorded by symptom diary', 'timeFrame': 'Every 24 hours through study completion, an average of 6 months'}, {'measure': 'Change in perceived cognitive impairment (self-report) as recorded by symptom diary', 'timeFrame': 'Every 24 hours through study completion, an average of 6 months', 'description': 'Severity of cognitive impairment experienced from multiple sclerosis'}, {'measure': 'Change in perceived depression or anxiety severity (self-report) as recorded by symptom diary', 'timeFrame': 'Every 24 hours through study completion, an average of 6 months', 'description': 'Severity of any mood disorders experienced from multiple sclerosis'}], 'secondaryOutcomes': [{'measure': 'Change in perceived walking instability (self-report) as recorded by symptom diary', 'timeFrame': 'Every 24 hours through study completion, an average of 6 months'}, {'measure': 'Change in perceived vision difficulties (self-report) as recorded by symptom diary', 'timeFrame': 'Every 24 hours through study completion, an average of 6 months'}, {'measure': 'Change in perceived Bowel/Bladder dysfunction (self-report) as recorded by symptom diary', 'timeFrame': 'Every 24 hours through study completion, an average of 6 months', 'description': 'Severity of bowel/bladder dysfunction experienced from multiple sclerosis'}, {'measure': 'Change in perceived sensory disturbance (self-report) as recorded by symptom diary', 'timeFrame': 'Every 24 hours through study completion, an average of 6 months'}, {'measure': 'Change in perceived vertigo severity (self-report) as recorded by symptom diary', 'timeFrame': 'Every 24 hours through study completion, an average of 6 months'}, {'measure': 'Change in perceived dysarthria severity (self-report) as recorded by symptom diary', 'timeFrame': 'Every 24 hours through study completion, an average of 6 months'}, {'measure': 'Change in pain (self-report) as recorded by symptom diary', 'timeFrame': 'Every 24 hours through study completion, an average of 6 months'}, {'measure': 'Change in sleep quality as recorded by app-linked wearable device', 'timeFrame': 'Every 24 hours through study completion, an average of 6 months'}, {'measure': 'Change in medication adherence (self-report) as recorded by medication diary', 'timeFrame': 'Every 24 hours through study completion, an average of 6 months'}, {'measure': 'Change in self-efficacy (self-report) as determined by the Multiple Sclerosis self-efficacy scale (survey instrument)', 'timeFrame': 'every three months, through study completion (an average of 6 months)'}, {'measure': 'Change in Multiple Sclerosis Quality of Life Inventory', 'timeFrame': "prompted based on the app user's responses on the daily surveys, up to 6 months", 'description': "The Multiple Sclerosis Quality of Life Inventory surveys are prompted based on the app user's responses on the daily surveys."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study subjects will be self-selecting from the national release of a mobile application.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be at least 18 years old\n* Live in the United States of America\n* Read/write in English\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02845635', 'briefTitle': 'MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'Pro00072319'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Relapsing Remitting Multiple Sclerosis', 'description': 'Those who document during the study on-boarding process that they suffer from relapsing-remitting multiple sclerosis.', 'interventionNames': ['Other: Personal history of multiple sclerosis']}, {'label': 'Primary Progressive Multiple Sclerosis', 'description': 'This who document during the on-boarding process that they suffer from primary progressive multiple sclerosis.', 'interventionNames': ['Other: Personal history of multiple sclerosis']}, {'label': 'Secondary Progressive Multiple Sclerosis', 'description': 'This who document during the on-boarding process that they suffer from secondary progressive multiple sclerosis.', 'interventionNames': ['Other: Personal history of multiple sclerosis']}, {'label': 'Control', 'description': 'This who document during the on-boarding process that they do not suffer from multiple sclerosis.', 'interventionNames': ['Other: Personal history of multiple sclerosis']}], 'interventions': [{'name': 'Personal history of multiple sclerosis', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Control', 'Primary Progressive Multiple Sclerosis', 'Relapsing Remitting Multiple Sclerosis', 'Secondary Progressive Multiple Sclerosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Fletcher L Hartsell, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}