Clincosm LogoSign in Get a demo

FORCE (Falls, Fracture, and Osteoporosis Risk Control Evaluation) Study

Sponsor
Group Health Centre (Other)
Overall Status
Completed
CT.gov ID
NCT00465387
Collaborator
Sault Area Hospital (Other), Algoma Community Care Access Centre (Other), Pharma Companies Alliance (Aventis and Proctor & Gamble) (Other), Merck Frosst Canada Ltd. (Industry), Eli Lilly and Company (Industry), The Green Shield Foundation (Other)
400
Enrollment
34.1
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Falls, Fractures & Osteoporosis Risk Assessment & Management
 N/A

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 Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Falls, Fracture, and Osteoporosis Risk Control Evaluation (FORCE) Study: A Randomized Controlled Trial With Community Partnerships in Northern Ontario
Study Start Date :
Mar 1, 2003
Actual Study Completion Date :
Jan 1, 2006

Outcome Measures

Primary Outcome Measures

  1. 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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Group Health Centre
  • 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

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00465387
Other Study ID Numbers:
  • FORCE1234
First Posted:
Apr 25, 2007
Last Update Posted:
Apr 25, 2007
Last Verified:
Apr 1, 2007
Additional relevant MeSH terms:
Osteoporosis

Study Results

No Results Posted as of Apr 25, 2007