Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-01-03 @ 8:24 PM
Study NCT ID:
NCT06803394
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-03-07
First Post:
2025-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hearing Health Equity Through Accessible Research and Solutions for Korean Americans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003142', 'term': 'Communication'}, {'id': 'D034381', 'term': 'Hearing Loss'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'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': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2025-01-27', 'studyFirstSubmitQcDate': '2025-01-27', 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hearing Handicap Inventory for the Elderly (HHIE-S) score', 'timeFrame': 'Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)', 'description': 'Score range 0-40. 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap.'}], 'secondaryOutcomes': [{'measure': 'Third Party Disability as assessed by the Significant Other Scale for Hearing Disability (SOS-HEAR)', 'timeFrame': 'Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)', 'description': 'Third-party disability will be measured in communication partners using the Significant Other Scale for Hearing Disability (SOS-HEAR). Score range 0-104, with higher score more disability.'}, {'measure': 'Relationship Quality as assessed by the Mutuality Scale', 'timeFrame': 'Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)', 'description': 'Relationship quality will be measured using the Mutuality Scale among participants and communication partners. Score range 0-60, with higher score better relationship quality.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Age-related Hearing Impairment', 'Personal Communication', 'Hearing Impairment', 'Hearing Loss', 'Community-dwelling Seniors', 'Korean']}, 'descriptionModule': {'briefSummary': "The objective of this study is to test the effect of a community-delivered, affordable, and accessible hearing care intervention on improving communication function and health-related quality of life among older Korean Americans (KA) and the older Korean American's care partners that integrates a low-cost over-the-counter amplification device and hearing rehabilitation in comparison to a 6-month delayed treatment group through a cluster randomized controlled study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'PARTICIPANT CRITERIA Participant inclusion criteria\n\n* Self-identified as first-generation KA in the target region\n* Age 60 years or older\n* Has a communication partner who lives in the same household or has at least weekly interactions\n* Screening audiometry Pure-tone audiometry (PTA)1,2,4 kilohertz (kHz) \\>25 decibel (dB) hearing loss (HL) in better ear\n* Hearing handicap as measured by HHIE-S score \\>=8 Participant exclusion criteria\n* Current use of hearing aid\n* Medical contraindications to use amplification device (e.g., draining ear)\n* Plan to move from the area within 6 months\n* Active treatment for a terminal illness or in hospice\n\nCOMMUNICATION PARTNER CRITERIA Communication Partner inclusion criteria\n\n* Age 18 years or older\n* Able to read and speak Korean\n* Lives with the older adult or has at least weekly interactions Communication Partner exclusion criteria\n* Plan to move from the area within 6 months\n* Active treatment for a terminal illness or in hospice'}, 'identificationModule': {'nctId': 'NCT06803394', 'acronym': 'K-HEARS', 'briefTitle': 'Hearing Health Equity Through Accessible Research and Solutions for Korean Americans', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Hearing Health Equity Through Accessible Research and Solutions for Korean Americans', 'orgStudyIdInfo': {'id': 'IRB00406742'}, 'secondaryIdInfos': [{'id': 'R01DC019686', 'link': 'https://reporter.nih.gov/quickSearch/R01DC019686', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate Treatment Site', 'description': 'Study site assigned to immediate treatment of K-HEARS intervention', 'interventionNames': ['Behavioral: K-HEARS Intervention', 'Device: K-HEARS Sound Amplifier Intervention']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Delayed Treatment Site', 'description': 'Study site assigned to 6-month delayed treatment of K-HEARS intervention', 'interventionNames': ['Behavioral: K-HEARS Intervention', 'Device: K-HEARS Sound Amplifier Intervention']}], 'interventions': [{'name': 'K-HEARS Intervention', 'type': 'BEHAVIORAL', 'description': 'Tailored aural rehabilitation for participant and care partner', 'armGroupLabels': ['Delayed Treatment Site', 'Immediate Treatment Site']}, {'name': 'K-HEARS Sound Amplifier Intervention', 'type': 'DEVICE', 'description': 'Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.', 'armGroupLabels': ['Delayed Treatment Site', 'Immediate Treatment Site']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins School of Nursing', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Hae-Ra Han, PhD,RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}