Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-02-20 @ 6:25 PM
Study NCT ID:
NCT02839759
Status:
COMPLETED
Last Update Posted:
2020-05-14
First Post:
2016-07-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hearing Aid Education and Adaptation System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D011304', 'term': 'Presbycusis'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-12', 'studyFirstSubmitDate': '2016-07-15', 'studyFirstSubmitQcDate': '2016-07-20', 'lastUpdatePostDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hearing Handicap Inventory for the Elderly (HHIE)', 'timeFrame': '8-12 weeks', 'description': 'Pre-post changes in the HHIE total scores'}], 'secondaryOutcomes': [{'measure': 'Communication Scale for Older Adults (CSOA)', 'timeFrame': '8-12 weeks', 'description': 'Pre-post changes in the CSOA communication strategies \\& attitudes scores'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hearing loss', 'Presbycusis', 'Aging', 'Teleaudiology'], 'conditions': ['Hearing Loss']}, 'descriptionModule': {'briefSummary': 'This RCT will have two arms: A control group that receives the standard of care from audiologists and an experimental group that receives both the standard of care and the at-home use of the TELLYHealth intervention. Subjects in each group will complete questionnaires at enrollment, mid-study and at the end of the study.', 'detailedDescription': 'HTM will develop the "TELLYHealth (tm) system" that will provide education on hearing aid use and maintenance. HTM will conduct a randomized controlled trial (RCT) to quantify the benefits of TELLYHealth to patients and audiologists including: reductions in hearing handicap, improved knowledge of hearing aid handling, use and communications strategies; and improved audiologist aftercare. The investigators will recruit 80 subjects (half in each group) and each subject will participate in the study for 8-12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Speaks and reads English fluently\n* Has mild (25-40 dB) to severe (70-95 dB) monaural sensorineural hearing loss\n* Will be fitted with one or two hearing aids at the time of enrollment\n* Owns a standard TV\n* Has Internet access at home\n* Has sufficient corrected vision to watch videos and read text on the TV and mobile device\n* No signs of dementia\n\nExclusion Criteria:\n\n* Lives with person who has enrolled in the study'}, 'identificationModule': {'nctId': 'NCT02839759', 'briefTitle': 'Hearing Aid Education and Adaptation System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Healthcare Technologies and Methods, LLC'}, 'officialTitle': 'Interactive Technology for Hearing Aid Education and Acceptance', 'orgStudyIdInfo': {'id': 'HTM092016'}, 'secondaryIdInfos': [{'id': 'R44AG045947', 'link': 'https://reporter.nih.gov/quickSearch/R44AG045947', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TELLYHealth Group', 'description': 'Subjects will receive the standard of care in hearing aid education and the TELLYHealth intervention for use over an 8 to12-week period and will be followed by their audiologist for 8 to 12 weeks.', 'interventionNames': ['Other: TELLYHealth']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care Group', 'description': 'Subjects will receive the standard of care in hearing aid education and will be followed by their audiologist for 8 to 12 weeks.'}], 'interventions': [{'name': 'TELLYHealth', 'type': 'OTHER', 'description': 'Educational videos and questions.', 'armGroupLabels': ['TELLYHealth Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32605', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Clear Sound Audiology', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '20852', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Potomac Audiology', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}], 'overallOfficials': [{'name': 'Alan M Letzt, M.S.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Healthcare Technologies and Methods, LLC'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'The date will be available approximately May 2025 for one year.', 'ipdSharing': 'YES', 'description': 'Aggregated data on hearing aid education will be shared.', 'accessCriteria': 'The criteria will be based on the policies of the selected data repository.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Healthcare Technologies and Methods, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}