The Winchester Falls Project

This study has been completed.

Sponsors and Collaborators:	Winchester and Eastleigh Healthcare NHS Trust Mid Hampshire Primary Care Trust Shire Pharmaceutical Development Procter and Gamble
Information provided by:	Winchester and Eastleigh Healthcare NHS Trust
ClinicalTrials.gov Identifier:	NCT00130624

Purpose

The study aims to determine whether multidisciplinary assessment of community-based patients, who have had at least one previous fall, reduces the rate of further falls and fall-related problems. The study also aims to determine whether such an intervention, if effective, is best carried out in a primary or secondary care setting.

Condition	Intervention	Phase
Accidental Falls	Procedure: Multidisciplinary intervention: primary or secondary care	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Winchester Falls Project: A Cluster Randomised Community Intervention Trial of Secondary Prevention of Falls in Community-Dwelling Older People

Further study details as provided by Winchester and Eastleigh Healthcare NHS Trust:

Primary Outcome Measures:

Proportion of patients in each group who had at least one further fall during follow up

Secondary Outcome Measures:

Death
Move to institutional care
Change in Barthel Score
Change in timed "get up and go" score
Fractures sustained as a result of a fall
Fall related admissions

Estimated Enrollment:	516
Study Start Date:	June 2001
Estimated Study Completion Date:	February 2005

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Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Over 65 years
At least two falls in the year preceding recruitment

Exclusion Criteria:

Life expectancy of less than 1 year
Plans to move from the area within 1 year
Abbreviated mental test score of less than 7/10
Non-english speaker without available interpreter
Nursing home resident

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130624

Locations

United Kingdom, Hampshire
Royal Hampshire County Hospital
Winchester, Hampshire, United Kingdom, SO22 5DG

Sponsors and Collaborators

Winchester and Eastleigh Healthcare NHS Trust

Mid Hampshire Primary Care Trust

Shire Pharmaceutical Development

Procter and Gamble

Investigators

Study Director:	Chris J Gordon, FRCP	Winchester and Eastleigh NHS Trust
Principal Investigator:	Claire Spice, MRCP	Winchester and Eastleigh NHS Trust

More Information

Study ID Numbers:	133/AB
Study First Received:	August 12, 2005
Last Updated:	October 4, 2005
ClinicalTrials.gov Identifier:	NCT00130624
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Winchester and Eastleigh Healthcare NHS Trust:

Falls
Elderly
multidisciplinary assessment

Study placed in the following topic categories:

Neoplasm Metastasis

ClinicalTrials.gov processed this record on January 16, 2009