Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-05 @ 5:14 PM
Study NCT ID:
NCT01963104
Status:
COMPLETED
Last Update Posted:
2019-11-26
First Post:
2013-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community-Based Kiosks for Hearing Screening and Education
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2048}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-22', 'studyFirstSubmitDate': '2013-09-12', 'studyFirstSubmitQcDate': '2013-10-11', 'lastUpdatePostDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Record which hearing screening method was best at motivating subjects to pursue hearing healthcare.', 'timeFrame': '4 years'}], 'primaryOutcomes': [{'measure': 'Record number of participants who sought hearing healthcare 6 months after the initial visit.', 'timeFrame': '4 years'}], 'secondaryOutcomes': [{'measure': 'Record number of participants whose attitude about hearing health care has changed 6 months after the initial visit.', 'timeFrame': '4 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hearing test, audiology, healthcare utilization,', 'patient education, hearing screening'], 'conditions': ['Hearing Loss']}, 'descriptionModule': {'briefSummary': 'The overall goal of the project is to evaluate innovative, cost-effective, community-based automated hearing screening and education methods to motivate individuals with mild-to-moderate hearing loss to enter the hearing healthcare system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: :\n\n* Some subjects will have a complaint of hearing difficulty without a recent hearing evaluation\n\nExclusion Criteria:\n\n* For all groups: minimum age 18 years. No current hearing aid use'}, 'identificationModule': {'nctId': 'NCT01963104', 'briefTitle': 'Community-Based Kiosks for Hearing Screening and Education', 'organization': {'class': 'FED', 'fullName': 'Portland VA Medical Center'}, 'officialTitle': 'Community-Based Kiosks for Hearing Screening and Education', 'orgStudyIdInfo': {'id': '4R33DC011769-02', 'link': 'https://reporter.nih.gov/quickSearch/4R33DC011769-02', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Automated hearing test', 'description': 'Subjects will take an abbreviated automated hearing test and then receive recommendations for hearing healthcare follow-up.', 'interventionNames': ['Procedure: Automated hearing test']}, {'type': 'EXPERIMENTAL', 'label': 'Pure-tone Screener test', 'description': 'Subjects will take a pure-tone hearing screening test and then receive recommendations for hearing healthcare follow-up.', 'interventionNames': ['Procedure: Pure-tone Screener test']}, {'type': 'EXPERIMENTAL', 'label': 'Digits-in-noise test', 'description': 'Subjects will take a digits-in-noise test and then receive recommendations for hearing healthcare follow-up.', 'interventionNames': ['Procedure: Digits-in-noise test']}, {'type': 'EXPERIMENTAL', 'label': 'No screening test', 'description': 'This group of subjects will not receive a screening test.', 'interventionNames': ['Procedure: No screening test']}, {'type': 'EXPERIMENTAL', 'label': 'Automated hearing test/Motivation video', 'description': 'Subjects will take an abbreviated automated hearing test and then receive recommendations for hearing healthcare follow-up. They will then watch a brief video that shows how hearing works and learn about the different types of hearing loss.', 'interventionNames': ['Procedure: Automated hearing test/Motivation video']}, {'type': 'EXPERIMENTAL', 'label': 'Pure-tone Screener/Motivation video', 'description': 'Subjects will take a pure-tone hearing screening test and then receive recommendations for hearing healthcare follow- up. They will then watch a brief video that shows how hearing works and learn about the different types of hearing loss.', 'interventionNames': ['Procedure: Pure-tone Screener/Motivation video']}, {'type': 'EXPERIMENTAL', 'label': 'Digits-in-noise test/Motivational video', 'description': 'Subjects will take a digits-in-noise test and then receive recommendations for hearing healthcare follow-up.They will then watch a brief video that shows how hearing works and learn about the different types of hearing loss.', 'interventionNames': ['Procedure: Digits-in-noise test/Motivational video']}, {'type': 'EXPERIMENTAL', 'label': 'No screening test/Motivational video', 'description': 'This group of subjects will not receive a screening test. They will watch a brief video that shows how hearing works and learn about the different types of hearing loss', 'interventionNames': ['Procedure: No screening test/Motivational video']}, {'type': 'EXPERIMENTAL', 'label': 'Home Hearing Screening Test', 'description': 'Subjects will be taught the set-up for a home hearing screening test, take an abbreviated automated hearing test and then receive recommendations for hearing healthcare follow-up.', 'interventionNames': ['Procedure: Home Hearing Screening Test']}, {'type': 'EXPERIMENTAL', 'label': 'Home Hearing Screening Test/Brief video', 'description': 'Subjects will be taught the set-up for a home hearing screening test, take an abbreviated automated hearing test and then receive recommendations for hearing healthcare follow-up.\n\nThey will then watch a brief video that shows how hearing works and learn about the different types of hearing loss.', 'interventionNames': ['Procedure: Home Hearing Screening Test/Brief video']}], 'interventions': [{'name': 'Automated hearing test', 'type': 'PROCEDURE', 'description': 'Subjects will take an automated hearing test that presents tones at different pitches and volumes. Participants will identify whether or not they heard the tone and receive printed recommendations for hearing healthcare follow-up. All subjects will complete the Hearing Handicap Inventory (HHI) questionnaire and the Hearing Beliefs Questionnaire (HBQ). Approximately 6-8 months after their initial appointment, subjects in this groups will receive a telephone call and will be asked questions related to their actions and attitudes related to hearing and hearing health care.', 'armGroupLabels': ['Automated hearing test']}, {'name': 'Pure-tone Screener test', 'type': 'PROCEDURE', 'description': 'During the test different tones are going to be presented at one volume level. Participants will identify whether or not they heard the tone and receive printed recommendations for hearing healthcare follow-up. All subjects will complete the Hearing Handicap Inventory (HHI) questionnaire and the Hearing Beliefs Questionnaire (HBQ). Approximately 6-8 months after their initial appointment, subjects in this groups will receive a telephone call and will be asked questions related to their actions and attitudes related to hearing and hearing health care.', 'armGroupLabels': ['Pure-tone Screener test']}, {'name': 'Digits-in-noise test', 'type': 'PROCEDURE', 'description': 'During the test subjects will hear a pattern of 3 numbers with variable noise in the background and identify the pattern they hear, and receive printed recommendations for hearing healthcare follow-up. All subjects will complete the Hearing Handicap Inventory (HHI) questionnaire and the Hearing Beliefs Questionnaire (HBQ). Approximately 6-8 months after their initial appointment, subjects in this groups will receive a telephone call and will be asked questions related to their actions and attitudes related to hearing and hearing health care.', 'armGroupLabels': ['Digits-in-noise test']}, {'name': 'No screening test', 'type': 'PROCEDURE', 'description': 'This group of subjects will not receive a screening test. All subjects will complete the Hearing Handicap Inventory (HHI) questionnaire and the Hearing Beliefs Questionnaire (HBQ). Approximately 6-8 months after their initial appointment, subjects in this group will receive a telephone call and will be asked questions related to their actions and attitudes related to hearing and hearing health care.', 'armGroupLabels': ['No screening test']}, {'name': 'Automated hearing test/Motivation video', 'type': 'PROCEDURE', 'description': 'Subjects will take an automated hearing test that presents tones at different pitches and volumes.Participants will identify whether or not they heard the tone and receive printed recommendations for hearing healthcare follow-up. They will also watch a brief video that shows how hearing works and learn about the different types of hearing loss. All subjects will complete the Hearing Handicap Inventory (HHI) questionnaire and the Hearing Beliefs Questionnaire (HBQ). Approximately 6-8 months after their initial appointment, subjects in this groups will receive a telephone call and will be asked questions related to their actions and attitudes related to hearing and hearing health care.', 'armGroupLabels': ['Automated hearing test/Motivation video']}, {'name': 'Pure-tone Screener/Motivation video', 'type': 'PROCEDURE', 'description': 'During the test different tones are going to be presented at one volume level. Participants will identify whether or not they heard the tone and receive printed recommendations for hearing healthcare follow-up. They will also watch a brief video that shows how hearing works and learn about the different types of hearing loss. All subjects will complete the Hearing Handicap Inventory (HHI) questionnaire and the Hearing Beliefs Questionnaire (HBQ). Approximately 6-8 months after their initial appointment, subjects in this group will receive a telephone call and will be asked questions related to their actions and attitudes related to hearing and hearing health care.', 'armGroupLabels': ['Pure-tone Screener/Motivation video']}, {'name': 'Digits-in-noise test/Motivational video', 'type': 'PROCEDURE', 'description': 'During the test subjects will hear a pattern of 3 numbers with variable noise in the background and identify the pattern they hear, and receive printed recommendations for hearing healthcare follow-up. They will also watch a brief video that shows how hearing works and learn about the different types of hearing loss. All subjects will complete the Hearing Handicap Inventory (HHI) questionnaire and the Hearing Beliefs Questionnaire (HBQ). Approximately 6-8 months after their initial appointment, subjects in this group will receive a telephone call and will be asked questions related to their actions and attitudes related to hearing and hearing health care.', 'armGroupLabels': ['Digits-in-noise test/Motivational video']}, {'name': 'No screening test/Motivational video', 'type': 'PROCEDURE', 'description': 'This group of subjects will not receive a screening test. They will watch a brief video that shows how hearing works and learn about the different types of hearing loss. All subjects will complete the Hearing Handicap Inventory (HHI) questionnaire and the Hearing Beliefs Questionnaire (HBQ). Approximately 6-8 months after their initial appointment, subjects in this group will receive a telephone call and will be asked questions related to their actions and attitudes related to hearing and hearing health care.', 'armGroupLabels': ['No screening test/Motivational video']}, {'name': 'Home Hearing Screening Test', 'type': 'PROCEDURE', 'description': 'Subjects will be taught the set-up for a home hearing screening test and will take an automated hearing test that presents tones at different pitches and volumes. Participants will identify whether or not they heard the tone and receive printed recommendations for hearing healthcare follow-up. All subjects will complete the Hearing Handicap Inventory (HHI) questionnaire and the Hearing Beliefs Questionnaire (HBQ). Approximately 6-8 months after their initial appointment, subjects in this groups will receive a telephone call and will be asked questions related to their actions and attitudes related to hearing and hearing health care.', 'armGroupLabels': ['Home Hearing Screening Test']}, {'name': 'Home Hearing Screening Test/Brief video', 'type': 'PROCEDURE', 'description': 'Subjects will be taught the set-up for a home hearing screening test and will take an automated hearing test that presents tones at different pitches and volumes. Participants will identify whether or not they heard the tone and receive printed recommendations for hearing healthcare follow-up. All subjects will complete the Hearing Handicap Inventory (HHI) questionnaire and the Hearing Beliefs Questionnaire (HBQ). They will also watch a brief video that shows how hearing works and learn about the different types of hearing loss.\n\nApproximately 6-8 months after their initial appointment, subjects in this groups will receive a telephone call and will be asked questions related to their actions and attitudes related to hearing and hearing health care.', 'armGroupLabels': ['Home Hearing Screening Test/Brief video']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33844', 'city': 'Bay Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Bay Pines VAHCS', 'geoPoint': {'lat': 27.81419, 'lon': -82.77816}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Portland VA Medical Center, National Center for Rehabilitative Auditory Research', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Martin P Feeney, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Portland VA Medical Center, National Center for Rehabilitative Auditory Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Portland VA Medical Center', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of NCRAR', 'investigatorFullName': 'M. Patrick Feeney', 'investigatorAffiliation': 'Portland VA Medical Center'}}}}