- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00463658
Interdisciplinary Falls Prevention for Seniors
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
Study Overview
Detailed Description
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.
The 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.
The 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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8P 4M3
- McMaster University - Faculty of Health Sciences at Frid
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Must be English speaking
- 75 years of age and over
- Newly referred to and eligible for personal support services
- Living at home in the community
- Identified as being at risk for falls
Exclusion Criteria:
- Refusal to give informed consent
- Unable to read/write English and a translator is not available
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
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.
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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.
Other Names:
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No Intervention: 2
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Number of self-reported falls: Falls surveillance report
Time Frame: 10 minutes
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10 minutes
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Health-Related Quality of Life and Function: SF-36 Health Survey
Time Frame: 15-20 minutes
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15-20 minutes
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Gait and Balance: Performance-Oriented Mobility Assessment
Time Frame: 10 minutes
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10 minutes
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Depression: Centre for Epidemiological Studies in Depression Scale
Time Frame: 5-10 minutes
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5-10 minutes
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Standardized Mini Mental State Examination
Time Frame: 20-25 minutes
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20-25 minutes
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Confidence in Performing Activities of Daily Living: Modified Falls Efficacy Scale
Time Frame: 5-10 minutes
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5-10 minutes
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Nutritional risk: Screen II Questionnaire
Time Frame: 10-15 minutes
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10-15 minutes
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Cost of Use of Health Services: Health and Social Services Utilization Questionnaire
Time Frame: 20 minutes
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20 minutes
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Caregiver burden: Caregiver Strain Index
Time Frame: 5-10 minutes
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5-10 minutes
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Maureen Markle-Reid, RN MScN PhD, School of Nursing, McMaster University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RFAAA0506164
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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