FORCE (Falls, Fracture, and Osteoporosis Risk Control Evaluation) Study
Primary Purpose
Osteoporosis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Falls, Fractures & Osteoporosis Risk Assessment & Management
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00465387
First Posted
April 24, 2007
Last Updated
April 24, 2007
Sponsor
Group Health Centre
Collaborators
Sault Area Hospital, Algoma Community Care Access Centre, Pharma Companies Alliance (Aventis and Proctor & Gamble), Merck Frosst Canada Ltd., Eli Lilly and Company, The Green Shield Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00465387
Brief Title
FORCE (Falls, Fracture, and Osteoporosis Risk Control Evaluation) Study
Official Title
Falls, Fracture, and Osteoporosis Risk Control Evaluation (FORCE) Study: A Randomized Controlled Trial With Community Partnerships in Northern Ontario
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Group Health Centre
Collaborators
Sault Area Hospital, Algoma Community Care Access Centre, Pharma Companies Alliance (Aventis and Proctor & Gamble), Merck Frosst Canada Ltd., Eli Lilly and Company, The Green Shield Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Falls, Fractures & Osteoporosis Risk Assessment & Management
Primary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia M. Ciaschini, MD, FRCPC
Organizational Affiliation
Group Health Centre, Sault Ste. Marie, ON, Canada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sharon E. Straus, MD MSc FRCPC
Organizational Affiliation
University of Toronto, ON, Canada
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
20799973
Citation
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.
Results Reference
derived
PubMed Identifier
18983670
Citation
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.
Results Reference
derived
Links:
URL
http://www.ghc.on.ca
Description
Group Health Centre website
Learn more about this trial
FORCE (Falls, Fracture, and Osteoporosis Risk Control Evaluation) Study
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