Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT01217502
Status:
COMPLETED
Last Update Posted:
2014-11-24
First Post:
2010-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Self-management for Dual Sensory Impaired
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D015354', 'term': 'Vision, Low'}], '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': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073278', 'term': 'Self-Management'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-21', 'studyFirstSubmitDate': '2010-09-13', 'studyFirstSubmitQcDate': '2010-10-07', 'lastUpdatePostDateStruct': {'date': '2014-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participation in social, leisure and communicative activities.', 'timeFrame': '6 months', 'description': '2 outcome measures will be used:\n\n* Activity Card Sort (Baum \\& Edwards 2001): change from baseline in leisure activities and social contacts at 6 months\n* Hearing Handicap Questionnaire (Gatehouse \\& Noble 2004): change from baseline in communicative contacts at 6 months'}], 'secondaryOutcomes': [{'measure': 'work satisfaction professional caregivers', 'timeFrame': '6 months'}, {'measure': 'Depressive feelings', 'timeFrame': '6 months'}, {'measure': 'Autonomy.', 'timeFrame': '6 months', 'description': 'Outcome measure: 9-item Patient Autonomy Questionnaire (Vernooij-Dassen \\& Osse 2005): change from baseline in dependency, losing control, and limitation of activities at 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Aged', 'Homes for the aged', 'Self management', 'Personal autonomy', 'Disease management', 'Self efficacy', 'Participation'], 'conditions': ['Hearing Loss', 'Low Vision']}, 'referencesModule': {'references': [{'pmid': '29371264', 'type': 'DERIVED', 'citation': 'Roets-Merken LM, Zuidema SU, Vernooij-Dassen MJFJ, Teerenstra S, Hermsen PGJM, Kempen GIJM, Graff MJL. Effectiveness of a nurse-supported self-management programme for dual sensory impaired older adults in long-term care: a cluster randomised controlled trial. BMJ Open. 2018 Jan 24;8(1):e016674. doi: 10.1136/bmjopen-2017-016674.'}, {'pmid': '27856482', 'type': 'DERIVED', 'citation': "Roets-Merken LM, Vernooij-Dassen MJ, Zuidema SU, Dees MK, Hermsen PG, Kempen GI, Graff MJ. Evaluation of nurses' changing perceptions when trained to implement a self-management programme for dual sensory impaired older adults in long-term care: a qualitative study. BMJ Open. 2016 Nov 17;6(11):e013122. doi: 10.1136/bmjopen-2016-013122."}, {'pmid': '24099315', 'type': 'DERIVED', 'citation': 'Roets-Merken LM, Graff MJ, Zuidema SU, Hermsen PG, Teerenstra S, Kempen GI, Vernooij-Dassen MJ. Effectiveness of a self-management program for dual sensory impaired seniors in aged care settings: study protocol for a cluster randomized controlled trial. Trials. 2013 Oct 7;14:321. doi: 10.1186/1745-6215-14-321.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to determine the effectiveness of a self-management program for elderly with an acquired and concurrent hearing and visual impairment due to age-related disease processes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of hearing loss and low vision\n* at least one sensory loss acquired after the age of 55\n* living in a home for the elderly\n\nExclusion Criteria:\n\n* congenital deaf persons\n* a dual sensory loss before the age of 55'}, 'identificationModule': {'nctId': 'NCT01217502', 'briefTitle': 'Self-management for Dual Sensory Impaired', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Self-management for Dual Sensory Impaired Older People and Their Caregivers: an Effective Approach?', 'orgStudyIdInfo': {'id': 'Kalorama 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self management', 'interventionNames': ['Behavioral: Self management program']}], 'interventions': [{'name': 'Self management program', 'type': 'BEHAVIORAL', 'otherNames': ['Empowerment'], 'description': 'Professional caregivers will be trained in offering a self management program to aged persons with a dual sensory impairment. Duration of the program: 6 months', 'armGroupLabels': ['Self management']}, {'name': 'self management program', 'type': 'BEHAVIORAL', 'otherNames': ['self efficacy'], 'description': 'Learning and practicing skills necessary to carry on an active and emotionally satisfying life in the face of the dual sensory impairment', 'armGroupLabels': ['Self management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4931HV', 'city': 'Geertruidenberg', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Foundation Riethorst Stromenland'}, {'zip': '6075HE', 'city': 'Herkenbosch', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Foundation Zorggroep Noord-Limburg', 'geoPoint': {'lat': 51.15333, 'lon': 6.06389}}, {'zip': '5171DA', 'city': 'Kaatsheuvel', 'state': 'North Brabant', 'country': 'Netherlands', 'facility': 'Maasduinen Foundation', 'geoPoint': {'lat': 51.6575, 'lon': 5.03472}}, {'zip': '2034MC', 'city': 'Haarlem', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Zorgbalans Foundation', 'geoPoint': {'lat': 52.38084, 'lon': 4.63683}}], 'overallOfficials': [{'name': 'M. Vernooij-Dassen, Prof. dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Radboud University Nijmegen Medical Centre, The Netherlands'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}