Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2025-12-29 @ 10:48 PM
Study NCT ID:
NCT01837550
Status:
COMPLETED
Last Update Posted:
2016-04-25
First Post:
2013-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Educational Program for Hearing Aid Users With Internet Support
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D010358', 'term': 'Patient Participation'}], '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': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'milijana.lundberg.malmberg@vgregion.se', 'phone': '0046 703 80 36 63', 'title': 'Milijana Malmberg, PhD student', 'organization': 'Sodra Alvsborg, Hearing Organisation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Directly after intervention (5 weeks), and 6 months post intervention', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Group', 'description': 'Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.', 'otherNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': "no professional support\n\nControl group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content.", 'otherNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Hearing Handicap Inventory for the Elderly (HHIE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.'}, {'id': 'OG001', 'title': 'Control Group', 'description': "no professional support\n\nControl group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."}], 'classes': [{'title': 'Pre-measurement', 'categories': [{'measurements': [{'value': '42.0', 'spread': '16.9', 'groupId': 'OG000'}, {'value': '36.1', 'spread': '11.8', 'groupId': 'OG001'}]}]}, {'title': 'Directly after-measurement (5 weeks)', 'categories': [{'measurements': [{'value': '35.8', 'spread': '15.2', 'groupId': 'OG000'}, {'value': '31.3', 'spread': '14.3', 'groupId': 'OG001'}]}]}, {'title': '6 months-post measurement', 'categories': [{'measurements': [{'value': '36.0', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '34.0', 'spread': '13.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.685', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': "To ensure a between-group effect of 80% at the 5% significance level it was estimated that 60 participants need to be included in the study. An effect size of Cohen's d=0.80 was expected. The expected standardized mean difference on the HHIE formed the basis for the obtained power."}], 'paramType': 'MEAN', 'timeFrame': '5 weeks, 6 months', 'description': 'The HHIE measures the experience of hearing loss in older people by focusing on the psycosocial and emotional effects of hearing loss. Higher score reflects a higher self-reported hearing problem. Minimum score for the total scale (reported) is 0 and maximum score is 100 points.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'International Outcome Inventory for Hearing Aids (IOI-HA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.'}, {'id': 'OG001', 'title': 'Control Group', 'description': "no professional support\n\nControl group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."}], 'classes': [{'title': '1. Daily use', 'categories': [{'measurements': [{'value': '4.1', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': '2. Benefit', 'categories': [{'measurements': [{'value': '3.8', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': '3. Remaining activity limitation', 'categories': [{'measurements': [{'value': '3.1', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': '4. Satisfaction', 'categories': [{'measurements': [{'value': '4.1', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': '5. Remaining participation restriction', 'categories': [{'measurements': [{'value': '3.8', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': '6. Impact on environment', 'categories': [{'measurements': [{'value': '3.6', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': '7. Quality of life', 'categories': [{'measurements': [{'value': '3.6', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-measurement', 'description': 'The IOI-HA measures hearing aid outcomes. The IOI-HA includes seven questions, measuring specific dimensions of hearing aid outcomes: daily use, benefits, remaining activity limitations, satisfaction, remaining participation restrictions, impact on the environment, and quality of life. Each question is scored from 1 to 5 (reported), where a higher score indicates a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The IOI-HA was used only at the pre-masurement point, to select descriptive data about the participants.'}, {'type': 'SECONDARY', 'title': 'Hospital Anxiety and Depression Scale (HADS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.'}, {'id': 'OG001', 'title': 'Control Group', 'description': "no professional support\n\nControl group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."}], 'classes': [{'title': 'Pre-measurement', 'categories': [{'measurements': [{'value': '8.5', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '4.8', 'groupId': 'OG001'}]}]}, {'title': 'Directly after-measurement (5 weeks)', 'categories': [{'measurements': [{'value': '7.5', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '5.2', 'groupId': 'OG001'}]}]}, {'title': '6 months post-measurement', 'categories': [{'measurements': [{'value': '4.8', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '5.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 weeks, 6 months', 'description': 'The HADS contains 14 items. Responses are scored from 0 to 3 and a higher score indicates more symptoms of anxiety and depression. Minimum score for the total scale (reported) is 0 and maximum score for the total scale is 42.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Communication Strategies Scale (CSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.'}, {'id': 'OG001', 'title': 'Control Group', 'description': "no professional support\n\nControl group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."}], 'classes': [{'title': 'Pre-measurement', 'categories': [{'measurements': [{'value': '68.1', 'spread': '13.6', 'groupId': 'OG000'}, {'value': '67.2', 'spread': '11.3', 'groupId': 'OG001'}]}]}, {'title': 'Directly after-measurement (5 weeks)', 'categories': [{'measurements': [{'value': '74.7', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '68.5', 'spread': '12.4', 'groupId': 'OG001'}]}]}, {'title': '6 months post-measurement', 'categories': [{'measurements': [{'value': '70.9', 'spread': '10.5', 'groupId': 'OG000'}, {'value': '66.7', 'spread': '11.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 weeks, 6 months', 'description': "CSS is designed to analyze participants' behavior in various communication situations. Scoring for CSS ranges from 1 almost never to 5 almost always for subscales Verbal- and Nonverbal Strategies and conversely for Maladaptive Behaviors; indicating how frequent a specific situation or behavior occurs. Minimum score for the total scale (reported) is 0 and maximum score for the total scale is 125.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Group', 'description': 'Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.'}, {'id': 'FG001', 'title': 'Control Group', 'description': "no professional support\n\nControl group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."}], 'periods': [{'title': 'T0-T1, 5 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'T0-T2, 6 Months Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '2013-2014; Borås Hospital, Sweden; Alingsås Hospital, Sweden; Skene Hospital, Sweden.', 'preAssignmentDetails': 'Participants who registered at the website and completed the screening form (n=108) were called for an interview to assess their eligibility; 104 informed an agreement to participate in the study. 14 of them did not fulfill the criteria for the Hearing Handicap Inventory for the Elderly, and 16 chose not to fill out the requested questionnaires.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Group', 'description': 'Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.'}, {'id': 'BG001', 'title': 'Control Group', 'description': "no professional support\n\nControl group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.8', 'spread': '11.9', 'groupId': 'BG000'}, {'value': '62.1', 'spread': '11.4', 'groupId': 'BG001'}, {'value': '62.0', 'spread': '11.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pure-tone average', 'classes': [{'title': 'Right ear', 'categories': [{'measurements': [{'value': '37.5', 'spread': '11.3', 'groupId': 'BG000'}, {'value': '38.0', 'spread': '8.6', 'groupId': 'BG001'}, {'value': '37.8', 'spread': '10.0', 'groupId': 'BG002'}]}]}, {'title': 'Left ear', 'categories': [{'measurements': [{'value': '37.8', 'spread': '10.5', 'groupId': 'BG000'}, {'value': '36.5', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '37.1', 'spread': '9.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measuring the presence of conductive or sensorineural hearing loss of a mild to moderate degree, i.e., 20-60 dB HL. Pure-tone average (PTA) measured across 500-, 1000-, and 2000 Hz.', 'unitOfMeasure': 'decibel Hearing Level', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Hearing Aids', 'classes': [{'title': 'Binaurally', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}, {'title': 'Monaurally', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'numbers'}, {'title': 'Use of hearing aid', 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '7.4', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '7.5', 'spread': '8.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-22', 'studyFirstSubmitDate': '2013-04-18', 'resultsFirstSubmitDate': '2016-01-12', 'studyFirstSubmitQcDate': '2013-04-22', 'lastUpdatePostDateStruct': {'date': '2016-04-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-22', 'studyFirstPostDateStruct': {'date': '2013-04-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Hearing Handicap Inventory for the Elderly (HHIE)', 'timeFrame': '5 weeks, 6 months', 'description': 'The HHIE measures the experience of hearing loss in older people by focusing on the psycosocial and emotional effects of hearing loss. Higher score reflects a higher self-reported hearing problem. Minimum score for the total scale (reported) is 0 and maximum score is 100 points.'}], 'secondaryOutcomes': [{'measure': 'International Outcome Inventory for Hearing Aids (IOI-HA)', 'timeFrame': 'pre-measurement', 'description': 'The IOI-HA measures hearing aid outcomes. The IOI-HA includes seven questions, measuring specific dimensions of hearing aid outcomes: daily use, benefits, remaining activity limitations, satisfaction, remaining participation restrictions, impact on the environment, and quality of life. Each question is scored from 1 to 5 (reported), where a higher score indicates a better outcome.'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': '5 weeks, 6 months', 'description': 'The HADS contains 14 items. Responses are scored from 0 to 3 and a higher score indicates more symptoms of anxiety and depression. Minimum score for the total scale (reported) is 0 and maximum score for the total scale is 42.'}, {'measure': 'Communication Strategies Scale (CSS)', 'timeFrame': '5 weeks, 6 months', 'description': "CSS is designed to analyze participants' behavior in various communication situations. Scoring for CSS ranges from 1 almost never to 5 almost always for subscales Verbal- and Nonverbal Strategies and conversely for Maladaptive Behaviors; indicating how frequent a specific situation or behavior occurs. Minimum score for the total scale (reported) is 0 and maximum score for the total scale is 125."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['audiologic rehabilitation', 'hearing loss', 'patient education', 'patient participation', 'structured rehabilitation', 'counseling', 'Internet'], 'conditions': ['Hearing Impaired']}, 'referencesModule': {'references': [{'pmid': '28592571', 'type': 'DERIVED', 'citation': 'Malmberg M, Lunner T, Kahari K, Andersson G. Evaluating the short-term and long-term effects of an internet-based aural rehabilitation programme for hearing aid users in general clinical practice: a randomised controlled trial. BMJ Open. 2017 Jun 6;7(5):e013047. doi: 10.1136/bmjopen-2016-013047.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the short-term effects of complementing an educational program for hearing aid users with Internet support.', 'detailedDescription': 'Aural rehabilitation aims to improve communication for people with hearing impairment. Education is widely regarded as an integral part of rehabilitation, but the effect of the delivery method of an educational program on the experience of hearing problems has rarely been investigated in controlled trials. Internet as a complement to aural rehabilitation has been tested in different studies with promising results. Though, until now not applied clinically as a part of an aural rehabilitation, focusing on hearing aid users with persistent self- reported hearing problems.\n\nThe purpose of this study was to evaluate the effect of an internet-based aural rehabilitation for hearing aid users from a clinical population.\n\nParticipants were randomly assigned to an intervention or control group. The intervention group followed a five-week program that consisted of reading material, home training assignments, online and telephone interaction with an audiologist, and participation in a discussion forum. The control group only had access to reading material.\n\nThe Hearing Handicap Inventory for the Elderly (HHIE), the Hospital Anxiety and Depression Scale (HADS) and the Communication Strategies Scale (CSS) were used to measure the outcomes of this study; and were recorded before and directly after the intervention as well as 6 months post-intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the hearing aid users to be between 20 and 80 yr of age,\n* the hearing aid users to have conductive or sensorineural hearing loss of mild to moderate degree (20-60 decibel Hearing Level pure-tone average measured across 500, 1000, and 2000 Hertz),\n* the hearing aid users to have completed a hearing aid fitting at least 3 months before the study began (regardless of hearing aid manufacturer, model, or hearing aid outcomes),\n* the hearing aid users to have a Hearing Handicap Inventory for the Elderly (HHIE) score of \\>20 points (indicative of some residual self-reported hearing problems),\n* the hearing aid users to provide informed consent to participate\n\nExclusion Criteria:\n\n* the hearing aid users who are not fulfilling the conditions to participate'}, 'identificationModule': {'nctId': 'NCT01837550', 'briefTitle': 'Educational Program for Hearing Aid Users With Internet Support', 'organization': {'class': 'OTHER', 'fullName': 'Sodra Alvsborgs Hospital'}, 'officialTitle': 'A Randomized, Controlled Trial Evaluating the Short- and Long-term Effects of an Internet-based Aural Rehabilitation Program for Hearing Aid Users Implemented in a General Clinical Practice', 'orgStudyIdInfo': {'id': 'HörNet VGR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'no professional support', 'interventionNames': ['Behavioral: Intervention group']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Professional support via Internet', 'interventionNames': ['Behavioral: Control group']}], 'interventions': [{'name': 'Intervention group', 'type': 'BEHAVIORAL', 'description': 'The intervention group followed a five-week program that consisted of reading material, home training assignments, online and telephone interaction with an audiologist, and participation in a discussion forum.', 'armGroupLabels': ['Control group']}, {'name': 'Control group', 'type': 'BEHAVIORAL', 'description': 'The control group only had access to reading material.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '501 82', 'city': 'Borås', 'state': 'Vastra Gotalandsregion', 'country': 'Sweden', 'facility': 'Hearing Clinic, Hearing Organization', 'geoPoint': {'lat': 57.72101, 'lon': 12.9401}}], 'overallOfficials': [{'name': 'Gerhard Andersson, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Clinical and Experimental Medicine, Division of Technical Audiology, Linkoping University, Sweden; Department of Behavioral Sciences and Learning, Swedish Institute.'}, {'name': 'Thomas Lunner, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Clinical and Experimental Medicine, Division of Technical Audiology, Linkoping University, Sweden; Oticon A/S, Research Centre Eriksholm, Snekkersten, Denmark.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sodra Alvsborgs Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD student, Principal Investigator', 'investigatorFullName': 'Milijana Malmberg', 'investigatorAffiliation': 'Sodra Alvsborgs Hospital'}}}}