Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2026-01-04 @ 9:35 AM
Study NCT ID:
NCT03255161
Status:
UNKNOWN
Last Update Posted:
2019-10-07
First Post:
2017-08-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Controlled Trial of a Community Health Worker Program on Hearing Loss (Oyendo Bien)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012657', 'term': 'Self-Help Groups'}], 'ancestors': [{'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-03', 'studyFirstSubmitDate': '2017-08-14', 'studyFirstSubmitQcDate': '2017-08-17', 'lastUpdatePostDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mean value for hearing-specific health-related quality of life at eight weeks post baseline as measured by a series of study-specific questions, some of which are adapted from the Self Assessment of Communication', 'timeFrame': '8 weeks', 'description': 'Participants rate the impact of hearing loss on various aspects of their lives, such as their emotional state and enjoyment of life.'}, {'measure': 'Communication function with partner: Mean frequency and severity of communication-related challenges as measured by a series of study-specific questions at eight weeks post baseline', 'timeFrame': '8 weeks', 'description': 'Frequency and difficulty of communication-related challenges resulting from hearing loss.'}, {'measure': 'Mean confidence in communication management at eight weeks post baseline as measured by a series of study-specific questions', 'timeFrame': '8 weeks', 'description': 'Participants rate their confidence in being able to manage their hearing loss and communication with family and other communication partners.'}], 'primaryOutcomes': [{'measure': 'Mean frequency of communication strategy use as measured at eight weeks post baseline for each of a series of study-specific strategies taught in the intervention', 'timeFrame': '8 weeks', 'description': 'Participants rate the frequency of use of each communication strategy on a five-point Likert scale. Communication strategies include such things as discussing hearing loss, talking face-to-face, and speaking slowly and clearly.'}], 'secondaryOutcomes': [{'measure': 'Mean number of hearing health actions taken and number of people who took each hearing health action at eight weeks post baseline', 'timeFrame': '8 weeks', 'description': 'Questionnaire includes 7 possible actions for managing hearing health or accessing hearing health care services (discussed with family, discussed with doctor, discussed with specialist, had a hearing test, used an assistive device, used a hearing aid, used hearing protection).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hearing Loss']}, 'referencesModule': {'references': [{'pmid': '35724253', 'type': 'DERIVED', 'citation': 'Marrone NL, Nieman CL, Coco L. Community-Based Participatory Research and Human-Centered Design Principles to Advance Hearing Health Equity. Ear Hear. 2022 Jul-Aug 01;43(Suppl 1):33S-44S. doi: 10.1097/AUD.0000000000001183. Epub 2020 Jun 13.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the effectiveness of a community health worker intervention to expand access to hearing health care among older adults facing health disparities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minimum age: 50 years\n* Audiometrically-confirmed hearing loss\n* Availability of a communication partner to attend the program with the participant\n* Be Spanish speaking and able to sign written informed consent\n\nExclusion Criteria:\n\n* Cognitive impairment'}, 'identificationModule': {'nctId': 'NCT03255161', 'briefTitle': 'Randomized Controlled Trial of a Community Health Worker Program on Hearing Loss (Oyendo Bien)', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'Oyendo Bien: Reducing Disparities in Access to Hearing Health Care on the U.S.-Mexico Border', 'orgStudyIdInfo': {'id': 'UArizona1'}, 'secondaryIdInfos': [{'id': 'R33DC013681', 'link': 'https://reporter.nih.gov/quickSearch/R33DC013681', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate communication education and support group', 'interventionNames': ['Behavioral: community health worker-audiologist communication education and support group']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist'}], 'interventions': [{'name': 'community health worker-audiologist communication education and support group', 'type': 'BEHAVIORAL', 'description': 'A 5-week educational program on hearing loss, communication strategies, and peer support facilitated by community health workers supervised by an audiologist.', 'armGroupLabels': ['Immediate communication education and support group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85621-1063', 'city': 'Nogales', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mariposa Community Health Center', 'geoPoint': {'lat': 31.34038, 'lon': -110.93425}}], 'overallOfficials': [{'name': 'Nicole Marrone, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arizona'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}