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Interdisciplinary Falls Prevention for Seniors
This study has been completed.
Sponsors and Collaborators: Hamilton Health Sciences
Canadian Patient Safety Institute
Mississauga Halton Community Care Access Centre
Hamilton-Niagara-Haldimand-Brant Community Care Access Centre
Ontario Ministry of Health and Long Term Care
Halton Region Health Department
Community Rehab
Information provided by: McMaster University
ClinicalTrials.gov Identifier: NCT00463658
  Purpose

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.


Condition Intervention Phase
Injuries
Other: Falls Prevention
Phase I

U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title: 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

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Number of self-reported falls: Falls surveillance report [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health-Related Quality of Life and Function: SF-36 Health Survey [ Time Frame: 15-20 minutes ] [ Designated as safety issue: No ]
  • Gait and Balance: Performance-Oriented Mobility Assessment [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
  • Depression: Centre for Epidemiological Studies in Depression Scale [ Time Frame: 5-10 minutes ] [ Designated as safety issue: No ]
  • Standardized Mini Mental State Examination [ Time Frame: 20-25 minutes ] [ Designated as safety issue: No ]
  • Confidence in Performing Activities of Daily Living: Modified Falls Efficacy Scale [ Time Frame: 5-10 minutes ] [ Designated as safety issue: No ]
  • Nutritional risk: Screen II Questionnaire [ Time Frame: 10-15 minutes ] [ Designated as safety issue: No ]
  • Cost of Use of Health Services: Health and Social Services Utilization Questionnaire [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
  • Caregiver burden: Caregiver Strain Index [ Time Frame: 5-10 minutes ] [ Designated as safety issue: No ]

Enrollment: 109
Study Start Date: May 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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.
Other: Falls Prevention
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.
2: No Intervention
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.

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.

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00463658

Locations
Canada, Ontario
McMaster University - Faculty of Health Sciences at Frid
Hamilton, Ontario, Canada, L8P 4M3
Sponsors and Collaborators
Hamilton Health Sciences
Canadian Patient Safety Institute
Mississauga Halton Community Care Access Centre
Hamilton-Niagara-Haldimand-Brant Community Care Access Centre
Ontario Ministry of Health and Long Term Care
Halton Region Health Department
Community Rehab
Investigators
Principal Investigator: Maureen Markle-Reid, RN MScN PhD School of Nursing, McMaster University
  More Information

Responsible Party: Committee on Scientific Development, McMaster University ( Ms. Marie Townsend )
Study ID Numbers: RFAAA0506164
Study First Received: April 18, 2007
Last Updated: May 5, 2008
ClinicalTrials.gov Identifier: NCT00463658  
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
Falls
Home Care
Aging Population
Clinical Effectiveness
Health Economics

ClinicalTrials.gov processed this record on January 16, 2009