Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
Study NCT ID:
NCT00463658
Status:
COMPLETED
Last Update Posted:
2008-05-07
First Post:
2007-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Interdisciplinary Falls Prevention for Seniors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-05', 'studyFirstSubmitDate': '2007-04-18', 'studyFirstSubmitQcDate': '2007-04-18', 'lastUpdatePostDateStruct': {'date': '2008-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of self-reported falls: Falls surveillance report', 'timeFrame': '10 minutes'}], 'secondaryOutcomes': [{'measure': 'Health-Related Quality of Life and Function: SF-36 Health Survey', 'timeFrame': '15-20 minutes'}, {'measure': 'Gait and Balance: Performance-Oriented Mobility Assessment', 'timeFrame': '10 minutes'}, {'measure': 'Depression: Centre for Epidemiological Studies in Depression Scale', 'timeFrame': '5-10 minutes'}, {'measure': 'Standardized Mini Mental State Examination', 'timeFrame': '20-25 minutes'}, {'measure': 'Confidence in Performing Activities of Daily Living: Modified Falls Efficacy Scale', 'timeFrame': '5-10 minutes'}, {'measure': 'Nutritional risk: Screen II Questionnaire', 'timeFrame': '10-15 minutes'}, {'measure': 'Cost of Use of Health Services: Health and Social Services Utilization Questionnaire', 'timeFrame': '20 minutes'}, {'measure': 'Caregiver burden: Caregiver Strain Index', 'timeFrame': '5-10 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Falls', 'Home Care', 'Aging Population', 'Clinical Effectiveness', 'Health Economics'], 'conditions': ['Injuries']}, 'referencesModule': {'references': [{'pmid': '28863774', 'type': 'DERIVED', 'citation': 'Isaranuwatchai W, Perdrizet J, Markle-Reid M, Hoch JS. Cost-effectiveness analysis of a multifactorial fall prevention intervention in older home care clients at risk for falling. BMC Geriatr. 2017 Sep 1;17(1):199. doi: 10.1186/s12877-017-0599-9.'}, {'pmid': '20202271', 'type': 'DERIVED', 'citation': "Markle-Reid M, Browne G, Gafni A, Roberts J, Weir R, Thabane L, Miles M, Vaitonis V, Hecimovich C, Baxter P, Henderson S. The effects and costs of a multifactorial and interdisciplinary team approach to falls prevention for older home care clients 'at risk' for falling: a randomized controlled trial. Can J Aging. 2010 Mar;29(1):139-61. doi: 10.1017/S0714980809990377."}, {'pmid': '20202270', 'type': 'DERIVED', 'citation': "Markle-Reid M, Browne G, Gafni A, Roberts J, Weir R, Thabane L, Miles M, Vaitonis V, Hecimovich C, Baxter P, Henderson S. A cross-sectional study of the prevalence, correlates, and costs of falls in older home care clients 'at risk' for falling. Can J Aging. 2010 Mar;29(1):119-37. doi: 10.1017/S0714980809990365."}]}, 'descriptionModule': {'briefSummary': 'With an aging population, an associated increase in the number of falls and fall injuries, there is a need to examine how health care services, such as home care, can best prevent falls among older people. This project will directly address this area by evaluating the effects and expense of an innovative approach to home care service delivery for older people at-risk for falls.', 'detailedDescription': "Falls and fall injuries are common-potentially preventable-causes of mortality, morbidity, functional decline, and increased health-care use and cost among community-living seniors over 75 years of age.\n\nThe knowledge gained from this project will directly address the Canadian Patient Safety Institute's priority areas for research in the Applied Health Services Research Stream by evaluating an innovative approach to reducing adverse events in a community-based (home care) setting.\n\nThe project will also identify the prevalence, determinants and costs of falls and fall injuries among older people requiring home care services. The design will be a two-armed; single blind randomized controlled trial of 110 older people 75 years and over, at risk for falls receiving hom care in Ontario. Subjects will be randomly allocated to either usual home care (control) or the interdisciplinary team. In the interdisciplinary group, a team of professional home care service providers, with specialized training in falls prevention, will proactively provide a comprehensive, coordinated and evidence based approach to falls prevention. The results will inform policies and practice related to the allocation and delivery of home care services for falls prevention across Canada."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be English speaking\n* 75 years of age and over\n* Newly referred to and eligible for personal support services\n* Living at home in the community\n* Identified as being at risk for falls\n\nExclusion Criteria:\n\n* Refusal to give informed consent\n* Unable to read/write English and a translator is not available'}, 'identificationModule': {'nctId': 'NCT00463658', 'briefTitle': 'Interdisciplinary Falls Prevention for Seniors', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'The Comparative Effects and Expenses of a Proactive Nurse-Led, Multifactorial and Interdisciplinary Team Approach to Falls Prevention for Older At-Risk Home Care Clients', 'orgStudyIdInfo': {'id': 'RFAAA0506164'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Subjects in the interdisciplinary group received home care services from a team of professional service providers (CCAC Case Manager, Registered Nurse, Occupational Therapist, Physiotherapist, Registered Dietician) with experience and training in falls prevention. The team provided a comprehensive, coordinated and evidence based approach to falls prevention through regular home visits, weekly case conferencing, a single accessible fall prevention plan,and joint client visits.', 'interventionNames': ['Other: Falls Prevention']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': "Participants allocated to the control group received standard home care services arranged by the CCAC. These include routine follow-up by the CCAC case manager whose focus is on assessing client's eligibility for in-home health services, arrangement and coordination of professional (i.e. nursing, occupational therapy, physiotherapy, social work, speech-language pathology, nutrition) and non-professional HSS, information and referral to community agencies, and ongoing monitoring and evaluating the plan of care through in-home assessments with clients."}], 'interventions': [{'name': 'Falls Prevention', 'type': 'OTHER', 'otherNames': ['Interdisciplinary Falls Prevention Team'], 'description': 'Subjects in the interdisciplinary group will receive home care services from a team of professional service providers (CCAC Case Manager, Public Health Nurse (Registered Nurse), Occupational Therapist, Physiotherapist, Nutritionist) with experience and training in falls prevention. The team will provide a comprehensive, coordinated and evidence based approach to falls prevention through weekly case conferencing, a written interdisciplinary care plan, and joint client visits.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8P 4M3', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster University - Faculty of Health Sciences at Frid', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Maureen Markle-Reid, RN MScN PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Nursing, McMaster University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Patient Safety Institute', 'class': 'OTHER'}, {'name': 'Mississauga Halton Community Care Access Centre', 'class': 'UNKNOWN'}, {'name': 'Hamilton Niagara Haldimand Brant Community Care Access Centre', 'class': 'OTHER'}, {'name': 'Ontario Ministry of Health and Long Term Care', 'class': 'OTHER_GOV'}, {'name': 'Halton Region Health Department', 'class': 'OTHER'}, {'name': 'Community Rehab', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Ms. Marie Townsend', 'oldOrganization': 'Committee on Scientific Development, McMaster University'}}}}