Falls prevention in older people Injury, Occupational Diseases, Poisoning Falls prevention in older people
Conditions
Interventions
The multifaceted podiatry intervention will consist of:
1. Footwear assessment and advice and financial assistance in purchasing more appropriate footwear if required.
Sponsors
University of York (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main REFORM cohort: Community dwelling men and women over 65 years of age Main REFORM trial: Community dwelling men and women over 65 years of age who have had one fall within the past 12 months or one fall which required hospital attention Added 21/08/2013: What are the effects of re-designed Participant Information Sheets (PIS)? A randomised controlled trial: All patients identified as potentially eligible for the REFORM study A nested randomised controlled trial of a leaflet containing information on research to increase recruitment rates of potential REFORM trial participants: The same as the main REFORM cohort
Exclusion criteria
Exclusion criteria: Main REFORM cohort and trial: 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 (10 m) 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 Added 21/08/2013: What are the effects of re-designed Participant Information Sheets (PIS)? A randomised controlled trial: There are no further exclusion criteria A nested randomised controlled trial of a leaflet containing information on research to increase recruitment rates of potential REFORM trial participants: The same as the main REFORM cohort and trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| REFORM main study Rate of falls i.e. falls/person/time over a 12-month period Added 21/08/2013: REFORM sub-study: What are the effects of a re-designed Participant Information Sheet? A randomised controlled trial. The recruitment rate, which is defined as the proportion of patients recruited to the REFORM trial. REFORM sub-study: A nested randomised controlled trial of a leaflet containing information on research to increase recruitment rates of potential REFORM trial participants. The recruitment rate, which is defined as the proportion of people who are randomised into the REFORM trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Added 21/08/2013: REFORM sub-study: What are the effects of a re-designed Participant Information Sheet? A randomised controlled trial. 1. The proportion of patients recruited to the REFORM cohort. 2. The proportion of recruited patients who are retained to the end of the REFORM study (trial and cohort) or the number remaining in the study six months prior to the end of the MRC START programme. 3. The number of ineligible patients in each intervention group. REFORM sub-study: A nested randomised controlled trial of a leaflet containing information on research to increase recruitment rates of potential REFORM trial participants. 1. Time to response i.e. the number of days elapsed between the recruitment pack being sent and returned to the York Trials Unit. 2. Rate of retention in the study. 3. Recruitment rate to the cohort, which can be defined as the proportion of eligible people who agree to take part in the REFORM study. | — |
Countries
Ireland, United Kingdom
Outcome results
None listed