Multifaceted podiatry intervention for fall prevention in patients over 65 years of age | Not Recruiting
Multifaceted podiatry intervention for fall prevention in patients over 65 years of age
REFORM
Trial Source

Health Conditions
  • Falls prevention in older people
Not Recruiting
Recruitment Status
ISRCTN68240461
Primary Trial ID Number
Summary
1. To develop a multifaceted podiatry intervention for fall prevention. 2. To test the feasibility of conducting a successful trial of the multifaceted podiatry intervention for fall prevention. 3. To establish the clinical effectiveness of the multifaceted podiatry intervention for fall prevention. 4. To examine the cost effectiveness of the multifaceted podiatry intervention for fall prevention. Added 21/08/2013: What are the effects of a re-designed Participant Information Sheet? A randomised controlled trial sub-study 1. To establish if the number of patients recruited to the REFORM study is improved by using a user-tested participant information sheet (PIS) and covering letter, or a PIS developed using a user-tested PIS template. 2. To explore whether changes to the design of the PIS/covering letter improves retention in the REFORM study. 3. To explore whether the quality of informed consent given by patients is affected by the type of PIS they initially receive. Study design: nested randomised controlled trial. A nested randomised controlled trial of a leaflet containing information on research to increase recruitment rates of potential REFORM trial participants. 1. To evaluate the effectiveness of a pre-notification leaflet (providing information on and detailing the importance of taking part in research) on improving participation in the REFORM study. Study design: nested randomised controlled trial. On 21/08/2013, the following changes were also made to the trial record: 1. The public title was changed from "Multifaceted podiatry intervention for fall prevention in patients over 70 years of age" to "Multifaceted podiatry intervention for fall prevention in patients over 65 years of age" 2. The scientific title was changed from "Randomised trial of a multifaceted podiatry intervention for fall prevention in patients over 70 years of age" to "Randomised trial of a multifaceted podiatry intervention for fall prevention in patients over 65 years of age" 3. Ireland was added to the countries of recruitment. 4. The target number of participants was changed from 890 to the following: Main REFORM study 1700 in the cohort and 890 in the randomised controlled trial REFORM sub-study: What are the effects of a re-designed Participant Information Sheets? A randomised controlled trial 2247 REFORM sub-study: A nested randomised controlled trial of a leaflet containing information on research to increase recruitment rates of potential REFORM trial participants 3300
Primary Outcome Measures
  • 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 Outcome Measures
  • 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.
Research Question
  • 1. To develop a multifaceted podiatry intervention for fall prevention. 2. To test the feasibility of conducting a successful trial of the multifaceted podiatry intervention for fall prevention. 3. To establish the clinical effectiveness of the multifaceted podiatry intervention for fall prevention. 4. To examine the cost effectiveness of the multifaceted podiatry intervention for fall prevention. Added 21/08/2013: What are the effects of a re-designed Participant Information Sheet? A randomised controlled trial sub-study 1. To establish if the number of patients recruited to the REFORM study is improved by using a user-tested participant information sheet (PIS) and covering letter, or a PIS developed using a user-tested PIS template. 2. To explore whether changes to the design of the PIS/covering letter improves retention in the REFORM study. 3. To explore whether the quality of informed consent given by patients is affected by the type of PIS they initially receive. Study design: nested randomised controlled trial. A nested randomised controlled trial of a leaflet containing information on research to increase recruitment rates of potential REFORM trial participants. 1. To evaluate the effectiveness of a pre-notification leaflet (providing information on and detailing the importance of taking part in research) on improving participation in the REFORM study. Study design: nested randomised controlled trial. On 21/08/2013, the following changes were also made to the trial record: 1. The public title was changed from "Multifaceted podiatry intervention for fall prevention in patients over 70 years of age" to "Multifaceted podiatry intervention for fall prevention in patients over 65 years of age" 2. The scientific title was changed from "Randomised trial of a multifaceted podiatry intervention for fall prevention in patients over 70 years of age" to "Randomised trial of a multifaceted podiatry intervention for fall prevention in patients over 65 years of age" 3. Ireland was added to the countries of recruitment. 4. The target number of participants was changed from 890 to the following: Main REFORM study 1700 in the cohort and 890 in the randomised controlled trial REFORM sub-study: What are the effects of a re-designed Participant Information Sheets? A randomised controlled trial 2247 REFORM sub-study: A nested randomised controlled trial of a leaflet containing information on research to increase recruitment rates of potential REFORM trial participants 3300
Design Type
Sorry, this information is not available
Ethics Approval
NRES committee - East of England - Cambridge East approved on 09/11/2011 Added 21/08/2013: NRES committee - East of England - Cambridge East approved the Participant Information Sheet sub-study on the 21/02/2013. NRES committee - East of England - Cambridge East approved the nested randomised controlled trial of a leaflet containing information on research to increase recruitment rates of potential REFORM trial participants on the 28/03/2013.
Publications
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25518875
Countries of Recruitment
Ireland; United Kingdom
Participant Sex
Both
Participant Age Range
Senior
Participant Type
Patient
Trial Sample Size
1700
Participant 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.
Participant 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.
Interventions
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 Added 21/08/2013: REFORM sub-study: What are the effects of a re-designed Participant Information Sheet? A randomised controlled trial. The intervention group will receive either a user-tested revised participant information sheet (PIS) and covering letter or a PIS written using a PIS user-tested template. The control group will receive PIS written in accordance with NRES guidance. 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 intervention group will be sent a leaflet providing information on, and detailing the importance of, taking part in research. The leaflet will be sent to them approximately two weeks prior to the REFORM recruitment pack being mailed out. The control group will receive no literature.
Design Details
Sorry, this information is not available
Study Design
Main REFORM study Cohort randomised controlled trial including prospective economic evaluation and a qualitative sub-study
Results Reporting
Sorry, this information is not available
Acronym
REFORM
Scientific Title
Randomised trial of a multifaceted podiatry intervention for fall prevention in patients over 65 years of age
Secondary Trial Identifying Number
HTA 09/77/01
Website
Sorry, this information is not available
Study Funded By
NIHR Health Technology Assessment Programme - HTA (UK) (09/77/01)
Funder Type
Sorry, this information is not available
Study Sponsored By
University of York (UK)
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment

01 Oct 2011

Recruitment End Date

01 Apr 2015

Trial End Date

01 Apr 2015

Date added to Registry

01 Jul 2011

Last Updated

23 Jul 2015