- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00465387
FORCE (Falls, Fracture, and Osteoporosis Risk Control Evaluation) Study
April 24, 2007 updated by: Group Health Centre
Falls, Fracture, and Osteoporosis Risk Control Evaluation (FORCE) Study: A Randomized Controlled Trial With Community Partnerships in Northern Ontario
Falls and osteoporosis-related fractures cause substantial morbidity and mortality in the elderly, and are an increasingly important public health concern.
A comprehensive multidisciplinary and integrated community-based approach is needed to identify and manage the population at highest risk of these complications.
Unfortunately, current gaps in continuity of care and health intervention result in a sub-optimal state of health service for these individuals.
The Falls, Fracture and Osteoporosis Risk Control and Evaluation (FORCE) Study is a two-year randomized controlled trial evaluated on the effect of coordinated community-based, multidisciplinary approach for fall and fracture prevention in Sault Ste.
Marie.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The FORCE partners are a broad collaboration of interested consumers, stakeholders and providers, led by the Algoma Health Unit (AHU) and the Group Health Centre (GHC) - a community-based, not-for-profit, multidisciplinary health organization.
Other partners include the multi-agency, consumer-orientated Algoma District Slips, Trips and Falls Committee, the Sault Area Hospital (SAH), the Algoma Community Care Access Centre (ACCAC), and Pharma Companies Alliance (Aventis and Proctor & Gamble), Merck Frosst and Lilly.
The Green Shield Foundation has also provided sponsorship.The results of this study might directly benefit up to eight thousand seniors in the district by providing the impetus to integrated, evidence-based health services.
Qualitative and quantitative research during this time will also be a unique opportunity to identify the modifiable barriers to the continuity and quality of care in this high-risk population.
By involving the community, the project will also educate those at future risk and hopefully prevent disease and complications.
Evaluation and research should provide nationally suggestions for better health service delivery.
Study Type
Interventional
Enrollment
400
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 55 years of age or older
- independent living within the city of Sault Ste. Marie, Ontario, Canada
- capable of providing informed consent
Exclusion Criteria:
- not at risk for falls
- unable to give informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Fall risk management, assessment and management of gate, strength and balance deficits, completion of medication review, including postural hypotension and psychotropic medications as well as the assessment and management of environmental risk factors.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Patricia M. Ciaschini, MD, FRCPC, Group Health Centre, Sault Ste. Marie, ON, Canada
- Principal Investigator: Sharon E. Straus, MD MSc FRCPC, University of Toronto, ON, Canada
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ciaschini PM, Straus SE, Dolovich LR, Goeree RA, Leung KM, Woods CR, Zimmerman GM, Majumdar SR, Spadafora S, Fera LA, Lee HN. Community based intervention to optimize osteoporosis management: randomized controlled trial. BMC Geriatr. 2010 Aug 27;10:60. doi: 10.1186/1471-2318-10-60.
- Ciaschini PM, Straus SE, Dolovich LR, Goeree RA, Leung KM, Woods CR, Zimmerman GM, Majumdar SR, Spadafora S, Fera LA, Lee HN. Community-based randomised controlled trial evaluating falls and osteoporosis risk management strategies. Trials. 2008 Nov 4;9:62. doi: 10.1186/1745-6215-9-62.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2003
Study Completion (Actual)
January 1, 2006
Study Registration Dates
First Submitted
April 24, 2007
First Submitted That Met QC Criteria
April 24, 2007
First Posted (Estimate)
April 25, 2007
Study Record Updates
Last Update Posted (Estimate)
April 25, 2007
Last Update Submitted That Met QC Criteria
April 24, 2007
Last Verified
April 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FORCE1234
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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