Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-01-12 @ 12:50 PM
Study NCT ID:
NCT05936320
Status:
COMPLETED
Last Update Posted:
2023-07-07
First Post:
2023-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Effects of Information Leaflets in Adult Aural Rehabilitation
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-30', 'studyFirstSubmitDate': '2023-06-22', 'studyFirstSubmitQcDate': '2023-06-30', 'lastUpdatePostDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knowledge about hearing aid functions', 'timeFrame': 'Baseline, 3 weeks postintervention', 'description': "Assessing change in knowledge about placement in noisy environments, telecoil function and directional microphones.\n\nOpen-ended questions where the knowledge assessed by two authors independently of each other, to make the answers quantitative. Interrater reliability was analysed with Cohen's kappa"}, {'measure': 'Perceived benefit', 'timeFrame': '3 weeks postintervention', 'description': 'Assessing the perceived benefit of the information leaflet through three items formulated as statements and ranged from (0) not agree at all to (10) completely agree.\n\nThe statements were as follows: 1) the written information I received has increased my understanding of the functions of the hearing aid, and 2) the written information I received has made me better understand how to position myself in different sound environments. If applicable, 3) the written information I received made it easier for me to explain the functions of my hearing aid to a communication partner.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aural rehabilitation', 'hearing aid functions', 'hearing aid knowledge', 'information leaflet', 'visual aids'], 'conditions': ['Hearing Impairment']}, 'descriptionModule': {'briefSummary': "Knowledge about how to manage hearing aids is an important factor in hearing aid success, but studies show that this knowledge ranges from good to poor, even among experienced adult hearing aid users. Information leaflets is a common tool in healthcare to give information with the purpose to increase theoretical knowledge and change behaviour, and illustrations in these leaflets can provide additional understanding for all kinds of patients.\n\nThe primary aim of this aural rehabiliation study was to evaluate participants' knowledge about placement in a noisy environment, directional microphone and telecoil function at baseline and postintervention and assessing their perceptions of the benefits of an information leaflet. Additional aim was to investigate whether, an information leaflet with illustrations and accompanying text about hearing aid functions have additional effects on participants' knowledge compared to an information leaflet without illustrations."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (18-80 years old) with hearing aids from 2012 or later\n\nExclusion Criteria:\n\n* Hearing aids without possibility to have activated directional microphones and telecoil\n* non-swedish speaking (e.g. need interpreter)'}, 'identificationModule': {'nctId': 'NCT05936320', 'briefTitle': 'Evaluating the Effects of Information Leaflets in Adult Aural Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Horselvarden Region Ostergotland'}, 'officialTitle': 'A Randomised Controlled Trial Evaluating Hearing Aid Knowledge and the Effects of Information Leaflets With and Without Illustrations', 'orgStudyIdInfo': {'id': 'Bildstöd'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Verbal information along with information leaflets containing text with illustrations about hearing aid functions', 'interventionNames': ['Behavioral: Information leaflets with illustrations about hearing aid functions']}, {'type': 'EXPERIMENTAL', 'label': 'Control group', 'description': 'Verbal information along with information leaflets containing text-only about hearing aid functions', 'interventionNames': ['Behavioral: Information leaflets with only text about hearing aid functions']}], 'interventions': [{'name': 'Information leaflets with illustrations about hearing aid functions', 'type': 'BEHAVIORAL', 'description': 'The information leaflet contains written information with simple illustrations about placement in noisy environments, how to use a telecoil and about directional microphones function in hearing aids. The time spent presenting the information leaflet was approximately ten minutes.', 'armGroupLabels': ['Intervention group']}, {'name': 'Information leaflets with only text about hearing aid functions', 'type': 'BEHAVIORAL', 'description': 'The information leaflet contains written information about placement in noisy environments, how to use a telecoil and about directional microphones function in hearing aids. The time spent presenting the information leaflet was approximately ten minutes.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58185', 'city': 'Linköping', 'state': 'Östergötland County', 'country': 'Sweden', 'facility': 'Hearing Clinic of the University Hospital Region Ostergotland', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}], 'overallOfficials': [{'name': 'Marie Öberg', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Horselvarden Region Ostergotland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Horselvarden Region Ostergotland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}