Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-03-02 @ 4:42 PM
Study NCT ID:
NCT01940705
Status:
COMPLETED
Last Update Posted:
2019-02-21
First Post:
2013-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Simplified Patient-Centered Educational Tool for Improved Hearing-Aid Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Gabrielle.Saunders@va.gov', 'phone': '503-220-8262', 'title': 'Gabrielle Saunders, PhD', 'phoneExt': '56210', 'organization': 'VA RR&D National Center for Rehabilitative Auditory Research'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Standard of Care', 'description': 'standard of care hearing-aid orientation as provided by clinical audiologist\n\nStandard of Care: standard of care hearing-aid orientation as provided by clinical audiologist', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 0, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'SoC Plus Hearing-aid Informational Guide', 'description': 'standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home informational guide regarding their hearing aids\n\nHearing-Aid Informational Guide: Printed take-home guide on hearing aids\n\nStandard of Care: standard of care hearing-aid orientation as provided by clinical audiologist', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'SoC Plus a Take-home DVD', 'description': 'standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home DVD regarding hearing aids\n\nHearing-Aid DVD: Take-home DVD about hearing aids\n\nStandard of Care: standard of care hearing-aid orientation as provided by clinical audiologist', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 0, 'seriousNumAtRisk': 61, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'SoC Plus Counseling With the Teach-back Technique', 'description': 'standard of care hearing-aid orientation as provided by clinical audiologist plus a teach-back technique counseling session reviewing information on the hearing aids\n\nTeach-back Technique: Counseling/Educational session using the teach-back technique to review information about their hearing aids\n\nStandard of Care: standard of care hearing-aid orientation as provided by clinical audiologist', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 0, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Non-study-related adverse event', 'notes': 'During testing when participant removed right hearing aid, the research audiologist noted the dome was missing. Otoscopy revealed the dome was stuck in the ear canal.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hearing Aid Skills and Knowledge Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'standard of care hearing-aid orientation as provided by clinical audiologist\n\nStandard of Care: standard of care hearing-aid orientation as provided by clinical audiologist'}, {'id': 'OG001', 'title': 'Standard of Care Plus Hearing-aid Informational Guide', 'description': 'standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home informational guide regarding their hearing aids\n\nHearing-Aid Informational Guide: Printed take-home guide on hearing aids\n\nStandard of Care: standard of care hearing-aid orientation as provided by clinical audiologist'}, {'id': 'OG002', 'title': 'Standard of Care Plus a Take-home Digital Video Disc', 'description': 'standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home DVD regarding hearing aids\n\nHearing-Aid digital video disc: Take-home digital video disc about hearing aids\n\nStandard of Care: standard of care hearing-aid orientation as provided by clinical audiologist'}, {'id': 'OG003', 'title': 'Standard of Care Plus Counseling With the Teach-back Technique', 'description': 'standard of care hearing-aid orientation as provided by clinical audiologist plus a teach-back technique counseling session reviewing information on the hearing aids\n\nTeach-back Technique: Counseling/Educational session using the teach-back technique to review information about their hearing aids\n\nStandard of Care: standard of care hearing-aid orientation as provided by clinical audiologist'}], 'classes': [{'title': 'Hearing Aid Skills and Knowledge Test Knowledge', 'categories': [{'measurements': [{'value': '65.4', 'spread': '12.2', 'groupId': 'OG000'}, {'value': '68.3', 'spread': '12.3', 'groupId': 'OG001'}, {'value': '66.2', 'spread': '11.8', 'groupId': 'OG002'}, {'value': '74.6', 'spread': '12.3', 'groupId': 'OG003'}]}]}, {'title': 'Hearing Aid Skills and Knowledge Test Skill', 'categories': [{'measurements': [{'value': '77.3', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '80.3', 'spread': '10.7', 'groupId': 'OG001'}, {'value': '78.9', 'spread': '9.4', 'groupId': 'OG002'}, {'value': '83.0', 'spread': '10.2', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '5.578', 'groupDescription': 'Analysis for Hearing Aid Skills and Knowledge test Skills scale', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '4.235', 'groupDescription': 'Analysis for Hearing Aid Skills and Knowledge test Knowledge scale', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks after the hearing-aid fitting', 'description': 'Hearing Aid Skills and Knowledge measures knowledge and skills for tasks associated with hearing aid management, such as knowledge of and ability to change batteries, insert the hearing aid, etc. For knowledge scale, participant gives a verbal response. Items are assigned points: 0 (incorrect response) or 1 (correct response). For skills scale, participant conducts the required task. Items are assigned points: 0 (Could not perform task), 1 (Achieved with some difficulty, more than one attempt) or 2 (Achieved with no difficulty on first attempt).\n\nThere were 15 knowledge items and 19 skill items. Percent correct was computed for each scale separately. Points were totaled, divided by the no. items with valid data, and multiplied by 100, with a correction to equate subscales.\n\nFor the skills scale, percent correct scores were calculated based upon the notion that a value of 2 was considered 100% correct, 1 was considered 50% correct.', 'unitOfMeasure': 'percentage of correct responses', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'standard of care hearing-aid orientation as provided by clinical audiologist\n\nStandard of Care: standard of care hearing-aid orientation as provided by clinical audiologist'}, {'id': 'OG001', 'title': 'SoC Plus Hearing-aid Informational Guide', 'description': 'standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home informational guide regarding their hearing aids\n\nHearing-Aid Informational Guide: Printed take-home guide on hearing aids\n\nStandard of Care: standard of care hearing-aid orientation as provided by clinical audiologist'}, {'id': 'OG002', 'title': 'SoC Plus a Take-home DVD', 'description': 'standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home DVD regarding hearing aids\n\nHearing-Aid DVD: Take-home DVD about hearing aids\n\nStandard of Care: standard of care hearing-aid orientation as provided by clinical audiologist'}, {'id': 'OG003', 'title': 'SoC Plus Counseling With the Teach-back Technique', 'description': 'standard of care hearing-aid orientation as provided by clinical audiologist plus a teach-back technique counseling session reviewing information on the hearing aids\n\nTeach-back Technique: Counseling/Educational session using the teach-back technique to review information about their hearing aids\n\nStandard of Care: standard of care hearing-aid orientation as provided by clinical audiologist'}], 'classes': [{'categories': [{'measurements': [{'value': '77.1', 'spread': '15.3', 'groupId': 'OG000'}, {'value': '78.4', 'spread': '11.5', 'groupId': 'OG001'}, {'value': '80.1', 'spread': '12.4', 'groupId': 'OG002'}, {'value': '80.9', 'spread': '14.4', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.414', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.956', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks after the hearing-aid fitting', 'description': '12-item questionnaire assessing self-efficacy for basic and advanced hearing aid handling skills. Item responses are on a scale of 0 to 100 in 10 point increments. Score of 0 = no self efficacy to100 = complete self efficacy. Final score is an average of individual item responses.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Questionnaire data are missing due to a technical issue for one individual in the SoC plus hearing-aid informational guide arm and one in the SoC plus counseling with the teach-back technique'}, {'type': 'SECONDARY', 'title': 'International Outcome Inventory for Hearing Aids.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'standard of care hearing-aid orientation as provided by clinical audiologist\n\nStandard of Care: standard of care hearing-aid orientation as provided by clinical audiologist'}, {'id': 'OG001', 'title': 'Standard of Care Plus Hearing-aid Informational Guide', 'description': 'standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home informational guide regarding their hearing aids\n\nHearing-Aid Informational Guide: Printed take-home guide on hearing aids\n\nStandard of Care: standard of care hearing-aid orientation as provided by clinical audiologist'}, {'id': 'OG002', 'title': 'Standard of Care Plus a Take-home Digital Video Disc', 'description': 'standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home DVD regarding hearing aids\n\nHearing-Aid digital video disc: Take-home digital video disc about hearing aids\n\nStandard of Care: standard of care hearing-aid orientation as provided by clinical audiologist'}, {'id': 'OG003', 'title': 'Standard of Care Plus Counseling With the Teach-back Technique', 'description': 'standard of care hearing-aid orientation as provided by clinical audiologist plus a teach-back technique counseling session reviewing information on the hearing aids\n\nTeach-back Technique: Counseling/Educational session using the teach-back technique to review information about their hearing aids\n\nStandard of Care: standard of care hearing-aid orientation as provided by clinical audiologist'}], 'classes': [{'categories': [{'measurements': [{'value': '29.3', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '29.7', 'spread': '4.5', 'groupId': 'OG001'}, {'value': '29.7', 'spread': '4.1', 'groupId': 'OG002'}, {'value': '30.0', 'spread': '4.0', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.847', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.270', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks after the hearing-aid fitting', 'description': 'Hearing-aid outcomes questionnaire assessing benefit, satisfaction, use, etc. Seven items, each on a scale of 1-5. 1 = low satisfaction/benefit/use etc., 5 = maximum satisfaction/benefit/use etc. A total score is derived by summing the score from each of the seven items. Total scores range from a low of 7 to a high of 35.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Questionnaire data are missing for one individual in the Standard of care arm, five in the SoC plus hearing-aid informational guide arm, five in the Standard of care plus a take-home digital video disc and two in the SoC plus counseling with the teach-back technique due to technical issues.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard of Care', 'description': 'standard of care hearing-aid orientation as provided by clinical audiologist\n\nStandard of Care: standard of care hearing-aid orientation as provided by clinical audiologist'}, {'id': 'FG001', 'title': 'Standard of Care Plus Hearing-aid Informational Guide', 'description': 'standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home informational guide regarding their hearing aids\n\nHearing-Aid Informational Guide: Printed take-home guide on hearing aids\n\nStandard of Care: standard of care hearing-aid orientation as provided by clinical audiologist'}, {'id': 'FG002', 'title': 'Standard of Care Plus a Take-home Digital Video Disc', 'description': 'standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home digital video disc regarding hearing aids\n\nHearing-Aid digital video disc : Take-home digital video disc about hearing aids\n\nStandard of Care: standard of care hearing-aid orientation as provided by clinical audiologist'}, {'id': 'FG003', 'title': 'Standard of Care Plus Counseling With the Teach-back Technique', 'description': 'standard of care hearing-aid orientation as provided by clinical audiologist plus a teach-back technique counseling session reviewing information on the hearing aids\n\nTeach-back Technique: Counseling/Educational session using the teach-back technique to review information about their hearing aids\n\nStandard of Care: standard of care hearing-aid orientation as provided by clinical audiologist'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '67'}, {'groupId': 'FG002', 'numSubjects': '69'}, {'groupId': 'FG003', 'numSubjects': '67'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '61'}, {'groupId': 'FG003', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Intervention not given', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by team - hearing aid change', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '269', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard of Care', 'description': 'standard of care hearing-aid orientation as provided by clinical audiologist\n\nStandard of Care: standard of care hearing-aid orientation as provided by clinical audiologist'}, {'id': 'BG001', 'title': 'SoC Plus Hearing-aid Informational Guide', 'description': 'standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home informational guide regarding their hearing aids\n\nHearing-Aid Informational Guide: Printed take-home guide on hearing aids\n\nStandard of Care: standard of care hearing-aid orientation as provided by clinical audiologist'}, {'id': 'BG002', 'title': 'SoC Plus a Take-home DVD', 'description': 'standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home DVD regarding hearing aids\n\nHearing-Aid DVD: Take-home DVD about hearing aids\n\nStandard of Care: standard of care hearing-aid orientation as provided by clinical audiologist'}, {'id': 'BG003', 'title': 'SoC Plus Counseling With the Teach-back Technique', 'description': 'standard of care hearing-aid orientation as provided by clinical audiologist plus a teach-back technique counseling session reviewing information on the hearing aids\n\nTeach-back Technique: Counseling/Educational session using the teach-back technique to review information about their hearing aids\n\nStandard of Care: standard of care hearing-aid orientation as provided by clinical audiologist'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.1', 'spread': '6.7', 'groupId': 'BG000'}, {'value': '68.7', 'spread': '7.6', 'groupId': 'BG001'}, {'value': '69.3', 'spread': '6.4', 'groupId': 'BG002'}, {'value': '68.8', 'spread': '7.0', 'groupId': 'BG003'}, {'value': '69.2', 'spread': '6.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}, {'value': '264', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '269', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 269}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2016-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-19', 'studyFirstSubmitDate': '2013-09-09', 'resultsFirstSubmitDate': '2017-09-18', 'studyFirstSubmitQcDate': '2013-09-09', 'lastUpdatePostDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-19', 'studyFirstPostDateStruct': {'date': '2013-09-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hearing Aid Skills and Knowledge Test', 'timeFrame': '4 weeks after the hearing-aid fitting', 'description': 'Hearing Aid Skills and Knowledge measures knowledge and skills for tasks associated with hearing aid management, such as knowledge of and ability to change batteries, insert the hearing aid, etc. For knowledge scale, participant gives a verbal response. Items are assigned points: 0 (incorrect response) or 1 (correct response). For skills scale, participant conducts the required task. Items are assigned points: 0 (Could not perform task), 1 (Achieved with some difficulty, more than one attempt) or 2 (Achieved with no difficulty on first attempt).\n\nThere were 15 knowledge items and 19 skill items. Percent correct was computed for each scale separately. Points were totaled, divided by the no. items with valid data, and multiplied by 100, with a correction to equate subscales.\n\nFor the skills scale, percent correct scores were calculated based upon the notion that a value of 2 was considered 100% correct, 1 was considered 50% correct.'}], 'secondaryOutcomes': [{'measure': 'The Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids', 'timeFrame': '4 weeks after the hearing-aid fitting', 'description': '12-item questionnaire assessing self-efficacy for basic and advanced hearing aid handling skills. Item responses are on a scale of 0 to 100 in 10 point increments. Score of 0 = no self efficacy to100 = complete self efficacy. Final score is an average of individual item responses.'}, {'measure': 'International Outcome Inventory for Hearing Aids.', 'timeFrame': '4 weeks after the hearing-aid fitting', 'description': 'Hearing-aid outcomes questionnaire assessing benefit, satisfaction, use, etc. Seven items, each on a scale of 1-5. 1 = low satisfaction/benefit/use etc., 5 = maximum satisfaction/benefit/use etc. A total score is derived by summing the score from each of the seven items. Total scores range from a low of 7 to a high of 35.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hearing aids', 'counseling', 'outcomes assessment (health care)', 'rehabilitation'], 'conditions': ['Hearing Loss']}, 'descriptionModule': {'briefSummary': "Hearing loss is the second most prevalent service-connected disability among Veterans. Hearing aids are the most common technological intervention for hearing loss. The VA, therefore, spends a considerable amount of money on them. Despite these expenditures, there are some Veterans who do not use their hearing aids successfully. Research has demonstrated that this inconsistent use may be related to a patient's inability to effectively take care of, and use, hearing aids. The proposed investigation will compare the effectiveness of three different tools for enhancing the educational efforts (hearing-aid orientation) typically provided by clinical audiologists when dispensing hearing aids. Each of these educational tools were developed using established methods for improving patient-provider communication. The investigators hypothesize that the use of these tools will result in better hearing-aid outcomes for Veteran patients than using the current standard-of-care procedures.", 'detailedDescription': "Objectives: Reasons for non-use of hearing aids are varied, but many studies have suggested that a lack of knowledge about how to use and/or take care of the hearing aids is a major factor. This is not surprising given that other healthcare fields have reported that between 40-80% of information provided during a clinical appointment is forgotten by the patient immediately after the appointment and almost half of what is remembered is not correct. The long-term goal of this project is to improve the delivery of information during the hearing-aid orientation, as better delivery of information will result in better hearing-aid handling skills and thus better overall hearing-aid outcomes. To accomplish this goal, the investigators propose to refine and evaluate the effectiveness of three forms of supplemental hearing-aid-orientation tools, each of which was developed using established guidelines for good patient-provider communication.\n\nPlan: The purpose of the proposed application is to evaluate the relative effectiveness of four forms of hearing-aid orientation provided to first time hearing-aid users, three of which use some of the aforementioned strategies to enhance the standard of care. The four forms of orientation will be: (1) the standard-of-care hearing-aid orientation; (2) the standard of care plus provision a hearing-aid information guide (HAIG) (3) the standard of care supplemented by an explanation of its content using the talk-back technique to confirm patient understanding; and (4) the standard of care plus provision of a take-home hearing-aid orientation DVD (HAO DVD). The content of the HAIG will be field tested and finalized following input obtained via focus groups with clinical audiologists and first-time hearing aid users.\n\nMethods: For the field testing up to 16 clinical audiologists and 10 new hearing aid user Veterans will be recruited to participate in focus groups during which they will view and then be asked questions about the content of the HAIG. Information learned during these focus groups will then be incorporated into the HAIG, at which time they will be ready for use in the study. For the comparative effectiveness study, up to 468 hearing-impaired Veterans who are about to become first-time hearing-aid users will be enrolled to participate in this investigation. These individuals will be recruited from the VA Portland Health Care System's Audiology and Speech Pathology Service (ASPS). Prior to receiving their hearing aids, subjects will be enrolled in the study at the National Center for Rehabilitative Auditory Research (NCRAR), and will conduct health literacy, manual dexterity and hepatic sensitivity, visual acuity, and learning and memory assessments. They will then attend their hearing aid fitting in the ASPS and will receive standard-of-care hearing-aid orientation. At the end of that appointment, they will receive one of the four study interventions. Subjects will return to the NCRAR 4-6 weeks after the hearing-aid-fitting appointment to complete the following outcome measures: a knowledge and practical test regarding hearing-aid use and care, a measure of self-efficacy, and a measure of hearing-aid outcomes. They also will be interviewed so that the investigators can learn their opinions about the intervention. A subset of the initial 50 participants enrolled into each study arm will attend a second follow-up appointment 6 months after the fitting appointment so the investigators can examine longer-term impacts of the hearing aid orientation interventions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nParticipants will be Veterans who are receiving hearing aids from the Audiology Clinic at the VA Portland Health Care System and who have had no prior experience using hearing aids. To be included in the study, participants will:\n\n* Be approved and have plans to get bilateral hearing aid fitting at the VA Portland Health Care System .\n* Be able to read and converse in English.\n\nExclusion Criteria:\n\n* Be younger than 50 years or older than 89 years of age.\n* Have a documented diagnosis of neurological, cognitive, visual, or other mental disorder, such as Alzheimer's disease, schizophrenia, current alcohol or substance abuse, as determined by chart review that would interfere with study completion."}, 'identificationModule': {'nctId': 'NCT01940705', 'briefTitle': 'A Simplified Patient-Centered Educational Tool for Improved Hearing-Aid Outcomes', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'A Simplified Patient Centered Educational Tool for Improved Hearing Aid Outcomes', 'orgStudyIdInfo': {'id': 'C1260-R'}, 'secondaryIdInfos': [{'id': '1I01RX001260-01', 'link': 'https://reporter.nih.gov/quickSearch/1I01RX001260-01', 'type': 'NIH'}, {'id': '3224', 'type': 'OTHER', 'domain': 'Portland VA IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of care (SoC)', 'description': 'standard of care hearing-aid orientation as provided by clinical audiologist', 'interventionNames': ['Other: Standard of Care']}, {'type': 'EXPERIMENTAL', 'label': 'SoC plus hearing-aid informational guide', 'description': 'standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home informational guide regarding their hearing aids', 'interventionNames': ['Other: Hearing-Aid Informational Guide', 'Other: Standard of Care']}, {'type': 'EXPERIMENTAL', 'label': 'SoC plus hearing aid DVD', 'description': 'SoC hearing-aid orientation as provided by clinical audiologist plus a take-home hearing aid digital video disc', 'interventionNames': ['Other: Hearing-Aid DVD', 'Other: Standard of Care']}, {'type': 'EXPERIMENTAL', 'label': 'Soc plus teach-back technique', 'description': 'standard of care hearing-aid orientation as provided by clinical audiologist plus a teach-back technique session reviewing information on the hearing aids', 'interventionNames': ['Behavioral: Teach-back Technique', 'Other: Standard of Care']}], 'interventions': [{'name': 'Hearing-Aid Informational Guide', 'type': 'OTHER', 'description': 'Printed take-home guide on hearing aids', 'armGroupLabels': ['SoC plus hearing-aid informational guide']}, {'name': 'Hearing-Aid DVD', 'type': 'OTHER', 'description': 'Take-home DVD about hearing aids', 'armGroupLabels': ['SoC plus hearing aid DVD']}, {'name': 'Teach-back Technique', 'type': 'BEHAVIORAL', 'description': 'Counseling/Educational session using the teach-back technique to review information about their hearing aids', 'armGroupLabels': ['Soc plus teach-back technique']}, {'name': 'Standard of Care', 'type': 'OTHER', 'description': 'standard of care hearing-aid orientation as provided by clinical audiologist', 'armGroupLabels': ['SoC plus hearing aid DVD', 'SoC plus hearing-aid informational guide', 'Soc plus teach-back technique', 'Standard of care (SoC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'VA Portland Health Care System, Portland, OR', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'M. Samantha Lewis, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Portland Health Care System, Portland, OR'}, {'name': 'Gabrielle H Saunders', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Portland Health Care System, Portland, OR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}