[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06803394":3,"trial-entities:NCT06803394":92,"trial-summary:NCT06803394":96},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":24,"study_type":25,"primary_purpose":13,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":44,"secondary_outcomes":49,"sex":56,"minimum_age":57,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":58,"std_ages":72,"locations":75,"central_contacts":85,"overall_officials":86,"references":90,"see_also_links":91},"NCT06803394","IRB00406742","Hearing Health Equity Through Accessible Research and Solutions for Korean Americans","ENROLLING_BY_INVITATION","2028-09-30","2026-03","2026-03-12","2025-02-09","Johns Hopkins University","OTHER",false,"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.",null,[18,19,20,21,22,23],"Age-related Hearing Impairment","Personal Communication","Hearing Impairment","Hearing Loss","Community-dwelling Seniors","Korean",[],"INTERVENTIONAL",[27],"NA",{"count":29,"type":30},800,"ESTIMATED",[32,39],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BEHAVIORAL","K-HEARS Intervention","Tailored aural rehabilitation for participant and care partner",[37,38],"Delayed Treatment Site","Immediate Treatment Site",{"type":40,"name":41,"description":42,"armGroupLabels":43},"DEVICE","K-HEARS Sound Amplifier Intervention","Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.",[37,38],[45],{"measure":46,"description":47,"timeFrame":48},"Hearing Handicap Inventory for the Elderly (HHIE-S) score","Score range 0-40. 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap.","Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)",[50,53],{"measure":51,"description":52,"timeFrame":48},"Third Party Disability as assessed by the Significant Other Scale for Hearing Disability (SOS-HEAR)","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":54,"description":55,"timeFrame":48},"Relationship Quality as assessed by the Mutuality Scale","Relationship quality will be measured using the Mutuality Scale among participants and communication partners. Score range 0-60, with higher score better relationship quality.","ALL","18 Years",{"inclusion":59,"exclusion":66,"raw_text":71},[60,61,62,63,64,65],"Self-identified as first-generation KA in the target region","Age 60 years or older","Has a communication partner who lives in the same household or has at least weekly interactions","Screening audiometry Pure-tone audiometry (PTA)1,2,4 kilohertz (kHz) \\>25 decibel (dB) hearing loss (HL) in better ear","Age 18 years or older","Able to read and speak Korean",[67,68,69,70,69,70],"Current use of hearing aid","Medical contraindications to use amplification device (e.g., draining ear)","Plan to move from the area within 6 months","Active treatment for a terminal illness or in hospice","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",[73,74],"ADULT","OLDER_ADULT",[76],{"facility":77,"city":78,"state":79,"zip":80,"country":81,"geoPoint":82},"Johns Hopkins School of Nursing","Baltimore","Maryland","21205","United States",{"lat":83,"lon":84},39.29038,-76.61219,[],[87],{"name":88,"affiliation":12,"role":89},"Hae-Ra Han, PhD,RN","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":93,"biomarkers":95},[94],"Presbycusis",[],{"nct_id":4,"found":14,"summary":16,"prompt_version":16}]