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Multifaceted Podiatry Intervention for Fall Prevention REFORM

REFORM: A Randomised trial of a multifaceted podiatry intervention for fall prevention in patients over 65 years of age

Specialty
Ageing (co-adopted by PrimaryCare)
Portfolio Eligibility
Automatically eligible
ISRCTN 68240461
EudraCT
MREC N° 11/EE/0379
UKCRN ID 11038
WHO ID
Research Summary
Falling is a common problem among people over the age of 65 years. It has been estimated that up to a third of people aged over 65 and half of people aged over 80 fall each year. Although most people do not hurt themselves when they fall, in about 10% of all cases, the person ends up with a serious injury. People often think that falls are an unavoidable result of getting older and that little can be done to stop them. It may not be possible to prevent falls completely, however, there are many different ways to help reduce the number of falls someone has. Previous research has suggested that foot problems and inappropriate footwear may increase the risk of falling. If this is the case then some treatments provided by podiatrists may help to prevent falls. In this study we would like to find out if a newly developed package of care delivered by a podiatrist can reduce the number of falls older people have. Design: We will recruit a group of 1,700 men and women over the age of 70 who have fallen to the REFORM cohort research study. These participants will be recruited from either podiatry clinics, GP practices or falls clinics in North Yorkshire, Sheffield and Leeds. 890 eligible participants will be randomly allocated in the REFORM trial. Participants will receive either a falls prevention leaflet and usual care from their podiatrist or GP (control group) or the newly developed package of podiatry care (intervention group). Ineligible participants will be assigned to the REFORM cohort. We will followup all participants for 12 months to see if they have fallen and look at their quality of life.
Study Type Interventional
Design Type Not specified
Disease(s) All Diseases
All Ageing
Phase N/A
Current Status Open
Closure Date 6/16/2014
Global Sample Size 1700
Global Recruitment to Date
98%
Geographical Scope UK Multi-Centre
Lead Country England
Open to new sites Yes, within lead country only
Main Inclusion Criteria
Cohort study:
1) Aged over 65 years
2) Provided informed consent and necessary baseline information
Pilot and Full trial:
1) Aged over 65 years
2) Has had one fall in the past 12 months or one fall in the past 24 months requiring hospitalisation.
3) Community dwelling.
4) The participant is willing to attend the podiatry clinic
5) The participant is willing to take part in the REFORM study
Main Exclusion Criteria
Cohort study exclusion criteria:
• Known life expectancy of less than six months
• Participants known to have dementia
• Participants known to have neuropathy
• Participants who have had a lower limb amputation
• Participants known to be chair or bed bound
Pilot and Full trial
Participants who are/with
1) Dementia
2) Neurodegenerative disorder
3) Do not complete the baseline or runin
data collection instruments adequately
4) Have a lower limb amputation or planned lower limb surgery within the three months following the planned initial assessment
5) Unable to walk household distances (10 metres) unaided.
6) Unable to read or speak English
7) Usual footwear has been adapted in such a way which would not allow an orthotic to be fitted.
Chief Investigator(s)
Prof David Torgerson
Further details, please contact
Mrs Sarah Cockayne

University of York
Department of Health Sciences
York Trials Unit
Area 4
Sebohm Rowntree Building
Heslington
York
North Yorkshire
YO10 5DD
UNITED KINGDOM

Tel: 01904 321 736
sarah.cockayne@york.ac.uk
Prof David Torgerson

University of York
Department of Health Sciences
York Trials Unit
Area 4
Sebohm Rowntree Building
Heslington
York
North Yorkshire
YO10 5DD
UNITED KINGDOM

Tel: 01904 321340
david.torgerson@york.ac.uk
Funder(s) NIHR Health Technology Assessment
Sponsor(s) University of York




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