Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-05 @ 11:38 AM
Study NCT ID:
NCT01829594
Status:
COMPLETED
Last Update Posted:
2013-04-11
First Post:
2013-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Case Managers to Frail Older People a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019090', 'term': 'Case Management'}], 'ancestors': [{'id': 'D010347', 'term': 'Patient Care Planning'}, {'id': 'D003191', 'term': 'Comprehensive Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-09', 'studyFirstSubmitDate': '2013-04-09', 'studyFirstSubmitQcDate': '2013-04-09', 'lastUpdatePostDateStruct': {'date': '2013-04-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Experiences of care', 'timeFrame': 'approximately one year', 'description': 'qualitative interviews with participants, next of kins and case managers'}], 'primaryOutcomes': [{'measure': 'Health care consumption', 'timeFrame': 'two years (one year before vs after baseline)'}, {'measure': 'Health care costs', 'timeFrame': 'two years (one year before vs after baseline)'}, {'measure': 'Feelings of loneliness', 'timeFrame': 'baseline and then after 3,6,9,12,24 months'}, {'measure': 'Depressive symptoms', 'timeFrame': 'baseline and then after 3,6,9,12,24 months'}, {'measure': 'Health Related Quality of Life', 'timeFrame': 'baseline and then after 3,6,9,12,24 months'}, {'measure': 'Number of falls', 'timeFrame': 'baseline and then after 3,6,9,12,24 months'}], 'secondaryOutcomes': [{'measure': 'Life Satisfaction', 'timeFrame': 'baseline and then after 6,12,24 months'}, {'measure': 'Health complaints', 'timeFrame': 'baseline and then after 3,6,9,12,24 months'}, {'measure': 'Knowledge about prescribed drugs', 'timeFrame': 'baseline and then after 3,6,9,12,24 months'}, {'measure': 'Attitudes towards prescribed drugs', 'timeFrame': 'baseline and then after 3,6,9,12,24 months'}, {'measure': 'Drug use', 'timeFrame': 'baseline and then after 3,6,9,12,24 months'}, {'measure': 'Activities and social participation', 'timeFrame': 'baseline and then after 3,6,9,12,24 months'}, {'measure': 'Functional capacity', 'timeFrame': 'baseline and then after 3,6,9,12,24 months'}, {'measure': 'Balance', 'timeFrame': 'baseline and then after 3,6,9,12,24 months'}, {'measure': 'Timed up and go (TUG)', 'timeFrame': 'baseline and then after 3,6,9,12,24 months'}, {'measure': 'Risk of falling', 'timeFrame': 'baseline and then after 3,6,9,12,24 months'}, {'measure': 'Fear of Falling', 'timeFrame': 'baseline and then after 3,6,9,12,24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Case Management', 'Frail Elderly', 'Health Services Administration', 'Delivery of Health Care', 'Accidental Falls', 'Health Status', 'Health Care Economics'], 'conditions': ['Frail Elderly']}, 'referencesModule': {'references': [{'pmid': '20409057', 'type': 'RESULT', 'citation': 'Kristensson J, Ekwall AK, Jakobsson U, Midlov P, Hallberg IR. Case managers for frail older people: a randomised controlled pilot study. Scand J Caring Sci. 2010 Dec;24(4):755-63. doi: 10.1111/j.1471-6712.2010.00773.x.'}]}, 'descriptionModule': {'briefSummary': 'The aim of is to test the effects of a model for care (case management) to older people with high healthcare consumption and functional dependency on healthcare consumption, quality of life, functional ability and experiences of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 65 or over\n* need help with at least two activities of daily living\n* been admitted to hospital on at least two occasions, or\n* have had at least four contacts with outpatient or primary care during the previous twelve months,\n* be able to communicate verbally\n* have no cognitive impairment'}, 'identificationModule': {'nctId': 'NCT01829594', 'briefTitle': 'Case Managers to Frail Older People a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Lund University'}, 'officialTitle': 'Case Managers to Frail Older People a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '499/2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Case Management', 'interventionNames': ['Other: Case management']}], 'interventions': [{'name': 'Case management', 'type': 'OTHER', 'description': "Nurses and a physiotherapist (PT) worked as case managers (CM). The intervention lasted 12 months and comprised 4 dimensions. The first was traditional CM tasks: assessment, planning, monitoring, care coordination and evaluation. Home visits were made at least once a month. The second and third was general and specific information related to the participants' situation. The fourth part included aspects of continuity and safety. The PT also paid home visits and made an assessment regarding physical function and balance. The intervention consisted of multidimensional prevention of falls and/or consequences of falls, and supporting and motivating the participant to increased physical activity. When those in the control group had participated for 12 months they were offered the intervention.", 'armGroupLabels': ['Case Management']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-22100', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Lund University, Faculty of Medicine, Department of Health Sciences', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Ingalill Rahm Hallberg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lund University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lund University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, Senior Lecturer', 'investigatorFullName': 'Jimmie Kristensson', 'investigatorAffiliation': 'Lund University'}}}}