Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-02-25 @ 9:41 PM
Study NCT ID:
NCT01260493
Status:
COMPLETED
Last Update Posted:
2014-07-15
First Post:
2010-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Continuum of Care for Frail Elderly People
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'synneve.dahlin-ivanoff@gu.se', 'phone': '+46 31 7865733', 'title': 'Professor Synneve Dahlin-Ivanoff ( Research leader)', 'organization': 'Vårdalinstitute, University of Gothenburg'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Conventional Care, Controlgroup', 'description': 'conventional care, control group', 'otherNumAtRisk': 76, 'otherNumAffected': 0, 'seriousNumAtRisk': 76, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Integrated Health Care Chain', 'description': 'integrated health care chain. Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers\n\nintegrated health care chain : Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers', 'otherNumAtRisk': 85, 'otherNumAffected': 0, 'seriousNumAtRisk': 85, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Health Care Consumption', 'timeFrame': '1 year', 'description': 'Number of hospital days and admission will be analysed', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Dependence in Activities of Daily Living', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Care, Controlgroup', 'description': 'conventional care, control group'}, {'id': 'OG001', 'title': 'Integrated Health Care Chain', 'description': 'integrated health care chain. Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers\n\nintegrated health care chain : Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001', 'lowerLimit': '1.03', 'upperLimit': '4.06'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Changes in number of person dependent in one or more daily activity from baseline to follow-up.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Satisfaction With Health and Social Care', 'timeFrame': '1 year', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Conventional Care, Controlgroup', 'description': 'conventional care, control group'}, {'id': 'FG001', 'title': 'Integrated Health Care Chain', 'description': 'integrated health care chain. Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers\n\nintegrated health care chain : Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '89'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '85'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'recrutment period October 2008 to July 2011', 'preAssignmentDetails': 'exluded due to sheltered housing (n=2), dementia (n=1),palliative care (n=1) and died before baseline (n=4), declined particapation (n=12)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Conventional Care, Controlgroup', 'description': 'conventional care, control group'}, {'id': 'BG001', 'title': 'Integrated Health Care Chain', 'description': 'integrated health care chain. Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers\n\nintegrated health care chain : Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '82.1', 'spread': '5.8', 'groupId': 'BG000'}, {'value': '82.7', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '82.4', 'spread': '5.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Sweden', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 181}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-11', 'studyFirstSubmitDate': '2010-11-30', 'resultsFirstSubmitDate': '2014-01-22', 'studyFirstSubmitQcDate': '2010-12-13', 'lastUpdatePostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-06-11', 'studyFirstPostDateStruct': {'date': '2010-12-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health Care Consumption', 'timeFrame': '1 year', 'description': 'Number of hospital days and admission will be analysed'}, {'measure': 'Dependence in Activities of Daily Living', 'timeFrame': '1 year', 'description': 'Changes in number of person dependent in one or more daily activity from baseline to follow-up.'}, {'measure': 'Satisfaction With Health and Social Care', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['very frail', 'case manager', 'integrated care', 'multiprofessional', 'intervention'], 'conditions': ['Frail Elderly People']}, 'referencesModule': {'references': [{'pmid': '23875866', 'type': 'DERIVED', 'citation': 'Eklund K, Wilhelmson K, Gustafsson H, Landahl S, Dahlin-Ivanoff S. One-year outcome of frailty indicators and activities of daily living following the randomised controlled trial: "Continuum of care for frail older people". BMC Geriatr. 2013 Jul 22;13:76. doi: 10.1186/1471-2318-13-76.'}, {'pmid': '22436121', 'type': 'DERIVED', 'citation': 'Hasson H, Blomberg S, Duner A. Fidelity and moderating factors in complex interventions: a case study of a continuum of care program for frail elderly people in health and social care. Implement Sci. 2012 Mar 22;7:23. doi: 10.1186/1748-5908-7-23.'}, {'pmid': '21569570', 'type': 'DERIVED', 'citation': 'Wilhelmson K, Duner A, Eklund K, Gosman-Hedstrom G, Blomberg S, Hasson H, Gustafsson H, Landahl S, Dahlin-Ivanoff S. Design of a randomized controlled study of a multi-professional and multidimensional intervention targeting frail elderly people. BMC Geriatr. 2011 May 14;11:24. doi: 10.1186/1471-2318-11-24.'}]}, 'descriptionModule': {'briefSummary': 'The present study "Continuum of care for frail elderly people" form part of the research programme "Support for frail elderly persons - from prevention to palliation" (www.vardalinstitutet.net) which comprises research into three interventions. The program comprises interventions addressing frail elderly people in different phases of the disablement process, from elderly people who are beginning to develop frailty to very frail elderly people receiving palliative care.\n\nThe intervention "Continuum of care for frail elderly people" addresses elderly people who are frail and that have a great risk of high health care consumption. The hypothesis is that an intervention program for frail elderly people can reduce the number of visits to the emergency department, increase the life satisfaction and maintain the functional ability. The intervention, including an early geriatric assessment at the emergency department, early family support, a case manager in the community with a multi-professional team and active follow-up by the case manager, contributes to early recognition of the elderly people\'s need of information, care and rehabilitation and of informal caregivers\' need of information. It enhances the transfer of information and integrates the care between different caregivers and different care levels, thereby better recognize frail elderly people\'s needs. Specifically, this study is expected to show that the intervention has a positive effect on the frail elderly person\'s functional ability, life satisfaction, satisfaction with health and social care, and health care consumption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 80 years and older or 65 to 79 years and having at least one chronic disease and being dependent in at least one activity of daily living\n\nExclusion Criteria:\n\n* acute severely sick who immediately needs the assessment of a physician (within ten minutes)\n* those with diagnosis of dementia (or severe cognitive impairment)\n* patients in palliative care'}, 'identificationModule': {'nctId': 'NCT01260493', 'briefTitle': 'Continuum of Care for Frail Elderly People', 'organization': {'class': 'OTHER', 'fullName': 'Vardalinstitutet The Swedish Institute for Health Sciences'}, 'officialTitle': 'Continuum of Care, From the Emergency Ward to Living at Home - Implementation and Evaluation of an Intervention for Frail Elderly People', 'orgStudyIdInfo': {'id': 'VårdkedjaVårdal'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Conventional care, controlgroup', 'description': 'conventional care, control group'}, {'type': 'EXPERIMENTAL', 'label': 'integrated health care chain', 'description': 'integrated health care chain. Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers', 'interventionNames': ['Other: integrated health care chain']}], 'interventions': [{'name': 'integrated health care chain', 'type': 'OTHER', 'description': 'Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers', 'armGroupLabels': ['integrated health care chain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '405 30', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'University of Gothenburg', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Katarina Wilhelmson, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Göteborg University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vardalinstitutet The Swedish Institute for Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'VinnVård', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}