Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-01-04 @ 1:45 AM
Study NCT ID:
NCT03138993
Status:
COMPLETED
Last Update Posted:
2019-09-26
First Post:
2017-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Older Adults' Decision Making for OSAT
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': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-24', 'studyFirstSubmitDate': '2017-02-14', 'studyFirstSubmitQcDate': '2017-05-01', 'lastUpdatePostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment rates', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'The investigators will measure recruitment rates for our recruitment strategies'}, {'measure': 'Enrollment rates', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'The investigators will measure enrollment rates'}], 'secondaryOutcomes': [{'measure': 'The length of time for completing the intervention session', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'The investigators will measure the length of time for completing the intervention session'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '32955013', 'type': 'DERIVED', 'citation': 'Fung CH, Martin JL, Liang LJ, Hays RD, Col N, Patterson ES, Josephson K, Mitchell MN, Sanchez MC, Aysola R, Song Y, Dzierzewski JM, Huang D, Zeidler M, Alessi C. Efficacy of a patient decision aid for improving person-centered decision-making by older adults with obstructive sleep apnea. J Clin Sleep Med. 2021 Feb 1;17(2):121-128. doi: 10.5664/jcsm.8798.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the feasibility of conducting a randomized controlled trial that tests a patient decision aid for obstructive sleep apnea in older adults with newly-diagnosed obstructive sleep apnea treated in an outpatient sleep clinic. Half of the participants will use a patient decision aid, while the other half will receive general information about sleep.', 'detailedDescription': "Patient decision aids are one strategy for helping older adults make informed decisions about treatments. Patient decision aids improve patients' knowledge about therapies and encourage them to actively weigh the risks and benefits of each therapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age \\>= 60 years\n2. diagnosed with obstructive sleep apnea on a sleep study\n3. able to read English-language newspaper text (if needed, using contact lens/glasses)\n4. able to write words in a paper booklet\n5. scheduled for a sleep clinic appointment with a UCLA sleep provider\n6. able to attend a sleep educational session prior to sleep clinic appointment\n\nExclusion Criteria:\n\n1. unable to provide informed consent\n2. dementia\n3. mild cognitive impairment diagnosis or Mini-Cog score \\< 3\n4. treated for obstructive sleep apnea for \\> 30 days prior to scheduled sleep education intervention\n5. severe physical or mental illness (e.g., hospitalized within past 7 days prior to scheduled sleep education intervention, substance abuse within 90 days of sleep education intervention)'}, 'identificationModule': {'nctId': 'NCT03138993', 'acronym': 'eDecide2Rest', 'briefTitle': "Improving Older Adults' Decision Making for OSAT", 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': "Improving Older Adults' Decision Making for Obstructive Sleep Apnea Treatment (Phase 3)", 'orgStudyIdInfo': {'id': '16001482'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patient decision aid', 'interventionNames': ['Behavioral: Patient decision aid']}, {'type': 'SHAM_COMPARATOR', 'label': 'General sleep education', 'interventionNames': ['Behavioral: General sleep education']}], 'interventions': [{'name': 'Patient decision aid', 'type': 'BEHAVIORAL', 'description': 'Web-based patient decision aid plus a paper workbook.', 'armGroupLabels': ['Patient decision aid']}, {'name': 'General sleep education', 'type': 'BEHAVIORAL', 'description': 'Web-based information about sleep plus a paper workbook', 'armGroupLabels': ['General sleep education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Constance Fung, MD, MSHS', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}