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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00463658
Other study ID # RFAAA0506164
Secondary ID
Status Completed
Phase Phase 1
First received April 18, 2007
Last updated May 5, 2008
Start date May 2006
Est. completion date August 2007

Study information

Verified date May 2008
Source McMaster University
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 109
Est. completion date August 2007
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender Both
Age group 75 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Canada McMaster University - Faculty of Health Sciences at Frid Hamilton Ontario

Sponsors (7)

Lead Sponsor Collaborator
Hamilton Health Sciences Corporation Canadian Patient Safety Institute, Community Rehab, Halton Region Health Department, Hamilton-Niagara-Haldimand-Brant Community Care Access Centre, Mississauga Halton Community Care Access Centre, Ontario Ministry of Health and Long Term Care

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of self-reported falls: Falls surveillance report 10 minutes No
Secondary Health-Related Quality of Life and Function: SF-36 Health Survey 15-20 minutes No
Secondary Gait and Balance: Performance-Oriented Mobility Assessment 10 minutes No
Secondary Depression: Centre for Epidemiological Studies in Depression Scale 5-10 minutes No
Secondary Standardized Mini Mental State Examination 20-25 minutes No
Secondary Confidence in Performing Activities of Daily Living: Modified Falls Efficacy Scale 5-10 minutes No
Secondary Nutritional risk: Screen II Questionnaire 10-15 minutes No
Secondary Cost of Use of Health Services: Health and Social Services Utilization Questionnaire 20 minutes No
Secondary Caregiver burden: Caregiver Strain Index 5-10 minutes No
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