Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT06068933
Status:
TERMINATED
Last Update Posted:
2025-04-06
First Post:
2023-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hearing Health for Korean American Older Adults With Mild Cognitive Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003142', 'term': 'Communication'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants in Phase 2-A MCI Focused Trial will be randomized into a two arms: immediate intervention and delayed intervention. Participants in Phase 2-B KA Older Adult Focused Trial will not be randomized.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'This study is being terminated due to insufficient participant recruitment within the projected timeframe', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2023-09-29', 'studyFirstSubmitQcDate': '2023-09-29', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-08', 'type': 'ACTUAL'}}, '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': 'Revised UCLA Loneliness Scale', 'timeFrame': 'Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)', 'description': 'Score is the sum of 20-item self-reported measure. Scores range from 20 to 80.\n\nScore ranges:\n\n20-34 - Low degree of loneliness 35-49 - Moderate degree of loneliness 50-64 - Moderately high degree of loneliness 65-80 - High degree of loneliness.'}, {'measure': 'Short Form-12 (SF-12) Mental Component Score', 'timeFrame': 'Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)', 'description': 'The 12-Item Short Form Survey (SF-12) measures the construct of self-reported health-related quality of life. Score ranges from 0-100 with higher scores indicating better mental health functioning.'}, {'measure': 'Social Network size Measured by Lubben Social Network Index', 'timeFrame': 'Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)', 'description': 'Measures social network size for both family and friends and also the frequency of interaction with them. Higher scores indicate higher level of social engagement. Score range (0-30).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Age-related Hearing Impairment', 'Personal Communication', 'Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to develop and assess the feasibility, acceptability, and preliminary efficacy of a community-delivered, affordable, and accessible hearing care intervention tailored to the needs of community-dwelling Korean American (KA) older adults with mild cognitive impairment (MCI) and their care partners that integrates a low-cost over-the-counter amplification device and hearing rehabilitation through a randomized controlled pilot study. Each dyad will consist of the study participant and their care partner.', 'detailedDescription': 'The study consists of three phases: 1) Phase 1: development of the intervention through exploratory focus groups and/or semi-structured interviews and prototyping via open-labeled trial 2) Phase 2A: randomized, controlled pilot study with study participants randomized to an immediate treatment group, versus a 6-month delayed treatment group of an intervention specific for individuals with MCI, 3) Phase 2B: a non-randomized pragmatic-focused trial of community-dwelling older KAs with hearing loss but without MCI, and 4) Phase 3: qualitative evaluation of the experience and supplemental feedback through exploratory focus groups and/or semi-structured interviews.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'PARTICIPANT INCLUSION CRITERIA FOR PHASE 2A: MCI-Pilot Trial\n\n* Age ≥ 60 years\n* Self-identified as first-generation Korean American\n* Self-reported ability to read and speak Korean\n* Hearing loss identified by screening audiometry pure-tone-average (PTA) 1, 2, 4 kilohertz \\> 25 decibel hearing loss in better hearing ear\n* Mild cognitive impairment (CDR=0.5 and/or Korean Montreal Cognitive Assessment (MoCA-K) \\<23)\n* Report not currently using a hearing aid\n* Has a care partner able to participate in the study\n* Stable medication regimen. Stable (for 2 weeks or longer) dosing of medication (e.g. antidepressants, antipsychotics) for neuropsychiatric symptoms\n\nPARTICIPANT INCLUSION CRITERIA FOR PHASE 2B: KA Older Adult-focused Trial:\n\n* Age ≥ 60 years\n* Self-identified as first-generation Korean American\n* Self-reported ability to read and speak Korean\n* Hearing loss identified by screening audiometry pure-tone-average (PTA) 1, 2, 4 kilohertz \\>= 35 decibel Hearing Loss in better hearing ear\n* Report not currently using a hearing aid\n* Has a care partner able to participate in the study\n\nCARE PARTNER INCLUSION CRITERIA (same for both Phase 2A and 2B)\n\n* Age 18 years or older\n* Able to read and speak Korean\n* Lives in the same household with the participant or has at least daily interactions\n* Aural-oral verbal communication as primary communication modality\n* Able to accompany participant to all study visits\n\nEXCLUSION CRITERIA (same for both Phase 2A and 2B)\n\nParticipant exclusion criteria\n\n* Residence in an assisted living facility (ALF) or nursing home (NH)\n* Medical contraindication to use of amplification device (e.g., draining ear)\n* Currently using a hearing aid or listening device\n\nCare partner exclusion criteria\n\n• Individuals who do not fulfill inclusion criteria'}, 'identificationModule': {'nctId': 'NCT06068933', 'acronym': 'K-HEARS MCI', 'briefTitle': 'Hearing Health for Korean American Older Adults With Mild Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'K-HEARS MCI: Hearing Health Care for Korean American Older Adults With Mild Cognitive Impairment - Pilot', 'orgStudyIdInfo': {'id': 'IRB00249500'}, 'secondaryIdInfos': [{'id': 'R56DC019686', 'link': 'https://reporter.nih.gov/quickSearch/R56DC019686', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 2A -MCI Pilot Trial Immediate Treatment Group', 'description': 'Immediate treatment with K-HEARS intervention', 'interventionNames': ['Behavioral: K-HEARS Intervention', 'Device: K-HEARS Sound Amplifier Intervention']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Phase 2A -MCI Pilot Trial Delayed Treatment Group', 'description': '6-month delayed treatment with K-HEARS intervention', 'interventionNames': ['Behavioral: K-HEARS Intervention', 'Device: K-HEARS Sound Amplifier Intervention']}, {'type': 'OTHER', 'label': 'Phase 2B -KA Older Adult Focused Trial (non-randomized)', 'description': 'Immediate treatment with 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': ['Phase 2A -MCI Pilot Trial Delayed Treatment Group', 'Phase 2A -MCI Pilot Trial Immediate Treatment Group', 'Phase 2B -KA Older Adult Focused Trial (non-randomized)']}, {'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': ['Phase 2A -MCI Pilot Trial Delayed Treatment Group', 'Phase 2A -MCI Pilot Trial Immediate Treatment Group', 'Phase 2B -KA Older Adult Focused Trial (non-randomized)']}]}, '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': 'JHU School Of Nursing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}