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Health Condition(s) or Problem
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Falls prevention in older people
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Lay Summary
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Background and study aims
Falling is a common problem among people over the age of 65 years. 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. This study is looking to see if a newly developed package of care from a podiatrist can help reduce the number of falls people over 70 years of age.
Who can participate?
Men and women aged 70 years and over who have fallen and live in the community can take part in this study.
What does the study involve?
If you agree to take part in the study you will be asked to complete a screening questionnaire and send it to the University of York?s Trials Unit. Researchers will then look at your answers to determine if you are eligible for the study.
If you are eligible for the study you will be asked to complete some additional questionnaires and monthly falls calendars. If you fall during the study we would like you to ring us and tell us what happened.
If you take part in the study you will be allocated to one of two groups: either the package of podiatry care group or the usual care group.
If you are allocated to the podiatrist package of care group, you will be asked to see a podiatrist at your local podiatry clinic on two occasions. The podiatrist will assess your footwear, measure your feet and fit an orthotic device (a type of insole which is worn in the shoe). You will then be shown some foot and ankle exercises and asked to do these at home three times a week.
If you are allocated to the usual care group, your GP care will continue as usual. If you are already seeing a podiatrist for treatment which is not related to the trial, you will continue to see them as usual. If you are not currently receiving treatment from a podiatrist, you will not be invited to attend the podiatry clinic.
What are the possible benefits and risks of participating?
We do not expect there will be any additional risks to taking part in the study. Whilst we cannot promise that taking part in this study will help you, the information we get from the study may help us find out how we can help improve balance and reduce the number of falls people have.
Where is the study run from?
We will be recruiting participants from podiatry clinics in England, in the Harrogate, Leeds, Scarborough, Sheffield and York areas.
When is study starting and how long is it expected to run for?
The study will start in Autumn 2011 and should end in Autumn 2015.
Who is funding the study?
The NIHR Health Technology Assessment Programme (HTA), UK.
Who is the main contact?
Mrs Sarah Cockayne (study coordinator)
+44 (0)1904 321736
sarah.cockayne@york.ac.uk (from ISRCTN)
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Who can enter the trial
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Men and women over 70 years of age who have had two falls within the past 12 months or one fall which required hospital attention
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Who cannot enter the trial
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1. Are known to have neuropathy
2. Are known to have a neurodegenerative disorder
3. Are known to have dementia
4. Are unable to walk household distances (10m)
5. Have had a lower limb amputation
6. Do not complete baseline or run-in data collection instruments adequately
7. Have footwear which has been adapted in such a way which would not allow an orthotic to be fitted
8. Are unable to read or speak English
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What will happen
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The multifaceted podiatry intervention will consist of:
1. Footwear assessment and advice and financial assistance in purchasing more appropriate footwear if required.
2. Routine podiatry care
3. Foot orthoses
4. Home based foot and ankle exercises
5. Falls prevention leaflet based on National Institute for Health and Clinical Excellence (NICE) guidance
Control group will receive:
Falls prevention leaflet based on NICE guidance
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Primary aim
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Rate of falls i.e. falls/person/time over a 12 month period
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Secondary Aim
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1. Proportion of fallers over a 12 month period
2. Proportion of multiple fallers over a 12 month period
3. Patient reported time to first fall during follow-up to 12 months
4. Health related quality of life EQ5D measured at baseline, 6 and 12 months
5. Short falls efficacy scale measured at baseline, 6 and 12 months
6. Fear of falling measured at baseline, 6 and 12 months
7. Activity of Daily Living measured at baseline, 6 and 12 months
8. Fracture rate over a 12 month period
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Participant Information Sheet
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Not available in web format, please use the contact details below to request a patient information sheet
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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York
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