Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-27 @ 11:49 PM
Study NCT ID:
NCT05786794
Status:
RECRUITING
Last Update Posted:
2025-09-05
First Post:
2023-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hearing Healthcare Assessment in Rural Communities
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062526', 'term': 'Patient Navigation'}], 'ancestors': [{'id': 'D018802', 'term': 'Patient-Centered Care'}, {'id': 'D011320', 'term': 'Primary Health Care'}, {'id': 'D003191', 'term': 'Comprehensive Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Approximately 500 patients from 10 rural clinics will be recruited to participate in the trial. All participants will complete baseline surveys and eligible candidates will engage with a Patient Navigator who will assist them in overcoming specific barriers to obtain a diagnostic audiogram with an audiologist.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2023-03-14', 'studyFirstSubmitQcDate': '2023-03-14', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Receiving a Diagnostic Audiogram After Enrollment', 'timeFrame': 'From Enrollment to Study Completion at 12 Months', 'description': 'Participants will be assisted to reduce barriers in scheduling a diagnostic audiogram within 12 months following enrollment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patient Navigator', 'Adult Hearing Screening', 'Adult Hearing Loss'], 'conditions': ['Hearing Loss, Adult-Onset', 'Hearing Loss, Age-Related']}, 'descriptionModule': {'briefSummary': 'Adult hearing loss in is the third most common chronic health condition in the United States. Adults living in rural areas face a higher risk of experiencing hearing loss, and more difficulty receiving testing and treatment than adults in urban settings. The goal of this clinical trial is to develop and test a community-based hearing healthcare patient navigation program in rural Kentucky. The main question this study aims to answer is:\n\n-Can the number of rural adults receiving diagnostic hearing tests be increased?', 'detailedDescription': 'Investigators will pilot test the rural hearing health care patient navigation program (N=500 patients from 10 rural clinics). The program will be evaluated with the following outcome: number of participants obtaining a diagnostic audiogram within past 12 months after enrollment among rural adults'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Able to speak, understand, and read English.\n* Patient of a participating primary care clinic\n\nExclusion Criteria:\n\n-Under 18'}, 'identificationModule': {'nctId': 'NCT05786794', 'acronym': 'HHARC', 'briefTitle': 'Hearing Healthcare Assessment in Rural Communities', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Hearing Healthcare Assessment in Rural Communities (HHARC)', 'orgStudyIdInfo': {'id': '65361'}, 'secondaryIdInfos': [{'id': 'R33DC019602', 'link': 'https://reporter.nih.gov/quickSearch/R33DC019602', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rural Clinic Hearing Healthcare Patient Navigation Program', 'description': 'This arm will involve pilot testing of the Patient Navigation Program with adults in rural primary care clinics', 'interventionNames': ['Behavioral: Patient Navigation Program for Hearing Health Care']}], 'interventions': [{'name': 'Patient Navigation Program for Hearing Health Care', 'type': 'BEHAVIORAL', 'description': 'Patients presenting for routine office visits will be invited to participate in the study and informed consent procedures and study enrollment will be conducted by a research assistant. Participants will then undergo baseline assessment. Following baseline measures, participants who screen positive for hearing loss will be contacted by the Patient Navigator (PN) to begin the intervention. The navigator will contact participants every 2 weeks to focus on addressing key aspects of Hearing Health Care (HHC): education, screening, diagnosis, and treatment. PNs will assist the patient to undergo a formal audiogram with the 12 months following enrollment. Each PN session will likely last between 10-30 minutes. Post-intervention data collection also administered by a trained interviewer, will occur following a diagnostic audiogram with an audiologist or at 12 months following enrollment.', 'armGroupLabels': ['Rural Clinic Hearing Healthcare Patient Navigation Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matthew Bush', 'role': 'CONTACT'}, {'name': 'Matthew L Bush', 'role': 'CONTACT', 'email': 'matthew.bush@uky.edu'}], 'facility': 'University of Kentucky Department of Otolaryngology', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'centralContacts': [{'name': 'Matthew L Bush, M.D.', 'role': 'CONTACT', 'email': 'matthew.bush@uky.edu', 'phone': '859-218-2167'}], 'overallOfficials': [{'name': 'Matthew L Bush, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Matthew Bush, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Matthew Bush, MD', 'investigatorAffiliation': 'University of Kentucky'}}}}