Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-01-06 @ 1:36 AM
Study NCT ID:
NCT03354520
Status:
WITHDRAWN
Last Update Posted:
2022-02-09
First Post:
2017-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing Treatment Effects on OSA-related Clinical and Patient-centered Outcomes Among Blacks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI departure from institution', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-07', 'studyFirstSubmitDate': '2017-11-21', 'studyFirstSubmitQcDate': '2017-11-24', 'lastUpdatePostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline OSA Self-Efficacy Scale Score to 6 Months Score', 'timeFrame': '2 Months and 6 Months', 'description': 'The mean of the nonmissing item responses was calculated for each of the 3 subscales: Perceived Risk, Outcome Expectancies, and Treatment Self-Efficacy. Using this mean-weighted score prevents the distortion of the score from missing responses. Factor 1 (Risk Perception consisting of 8 questions); Factor 2 (Outcome Expectancy consisting of 9 items) and Factor 3 (Treatment Self Efficacy consisting of 9 items) are given a potential score of 1-4.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'The study is to maximize efficacy of message delivery to achieve desired Obstructive sleep apnea (OSA) adherence goal. Newly diagnosed black patients (n=390, all genders) from participating sleep clinics will be randomly exposed to either the individually tailored or standard OSA messages. Investigators will look at an effective and scalable intervention to improve OSA-related outcomes: a) clinical CVD and brain health measures and b) patient-centered outcomes. Patient-centered and adherence data will be captured via REDCap, enabling real-time application of data-driven decision rules while implementing the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-reported race/ethnicity as African American, African, Caribbean or black\n* Accessible by phone\n* No plans to move away within the year\n* OSA diagnosis, consent, including permission to release medical data\n* Physician-diagnosed medical conditions.\n\nExclusion Criteria:\n\n* Progressive illnesses in which disability or death is expected within 1 year\n* Impaired cognitive/ functional ability precluding participation\n* Intention to move within the same year of enrollment\n* Family member currently enrolled'}, 'identificationModule': {'nctId': 'NCT03354520', 'briefTitle': 'Optimizing Treatment Effects on OSA-related Clinical and Patient-centered Outcomes Among Blacks', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Optimizing Treatment Effects on OSA-related Clinical and Patient-centered Outcomes Among Blacks', 'orgStudyIdInfo': {'id': '17-01097'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tailored Videos', 'interventionNames': ['Behavioral: Tailored Videos']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Videos', 'interventionNames': ['Behavioral: Standard Videos']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'OSA Treatment', 'interventionNames': ['Behavioral: OSA Treatment']}], 'interventions': [{'name': 'Tailored Videos', 'type': 'BEHAVIORAL', 'description': 'web-based OSA messages (videos featuring role models and coaching advice using motivational enhancement) addressing OSA barriers within a health literacy framework--to decrease cognitive load and render messages understandable and actionable. OSA messages were tailored based on focus group data in the previous study (group tailoring).', 'armGroupLabels': ['Tailored Videos']}, {'name': 'OSA Treatment', 'type': 'BEHAVIORAL', 'description': 'Web-based platform delivering messages promoting OSA self-efficacy. . All patients will view the introductory video, followed by the video cluster: Sleep, Health, and Well-Being; Sleep-Heart Health; Lifestyle Changes; and Sleep Hygiene.', 'armGroupLabels': ['OSA Treatment']}, {'name': 'Standard Videos', 'type': 'BEHAVIORAL', 'description': 'Patients in the control arm will also receive an iPad, providing access to standard online OSA health information (e.g., National Sleep Foundation) in an equivalent dose as in the intervention arm using pre-selected automatic alerts to access the website', 'armGroupLabels': ['Standard Videos']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Girardin Jean-Louis, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 3 months and ending 5 years following article publication.', 'ipdSharing': 'YES', 'description': 'All of the individual participant data collected during the trial, after deidentification.', 'accessCriteria': 'Requests should be directed to Ferdinand.Zizi@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}