Plain English Summary
Main REFORM study
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 65 years of age.
Who can participate?
Men and women aged 65 and over who have fallen and live in the community
What does the study involve?
Participants are asked to complete a screening questionnaire and send it to the University of York's Trials Unit. Researchers then look at the answers to determine if they are eligible for the study. If they are eligible for the study they are asked to complete some additional questionnaires and monthly falls calendars. If they fall during the study the participants contact the researchers and tell them what happened. Participants are randomly allocated to one of two groups: either the package of podiatry care group or the usual care group. If they are allocated to the podiatrist package of care group, they are asked to see a podiatrist at their local podiatry clinic on two occasions. The podiatrist assesses their footwear, measures their feet and fits an orthotic device (a type of insole which is worn in the shoe). They are then shown some foot and ankle exercises and asked to do these at home three times a week. If they are allocated to the usual care group, GP care continues as usual. If participants are already seeing a podiatrist for treatment which is not related to the study, they continue to see them as usual. If they are not currently receiving treatment from a podiatrist, they are not be invited to attend the podiatry clinic.
What are the possible benefits and risks of participating?
Whilst it cannot promised that taking part in this study will help the participants, the information obtained may help find out how to improve balance and reduce the number of falls people have. No additional risks are expected.
Where is the study run from?
Podiatry clinics in England, in the Harrogate, Leeds, Scarborough, Sheffield and York areas (UK)
When is the study starting and how long is it expected to run for?
October 2011 to April 2015
Who is funding the study?
NIHR Health Technology Assessment Programme (HTA) (UK)
Who is the main contact?
Mrs Sarah Cockayne
sarah.cockayne@york.ac.uk
What are the effects of a re-designed Participant Information Sheet? A randomised controlled trial sub-study
Background and study aims
It has been suggested that patients can be put off from taking part in research studies because the written information they are given is too long and difficult to understand. This study is looking to see if the information given to patients can be improved.
Who can participate?
Anyone who is approached to take part in the REFORM study
What does the study involve?
Potential participants are sent one of three information sheets and are sked to fill in a questionnaire about the information they received.
What are the possible benefits and risks of participating?
Whilst it cannot be promised that taking part in this study will help the participants, the information obtained may help to provide better information to potential study participants. No additional risks are expected.
Where is the study run from?
Podiatry clinics in England, in the Harrogate, Leeds, Scarborough, Sheffield and North Yorkshire areas (UK)
When is the study starting and how long is it expected to run for?
Spring 2013 to Autumn 2013
Who is funding the study?
NIHR Health Technology Assessment Programme (HTA) (UK)
Who is the main contact?
Mrs Sarah Cockayne
sarah.cockayne@york.ac.uk
A nested randomised controlled trial of a leaflet containing information on research to increase recruitment rates of potential REFORM trial participants
Background and study aims
Many trials find it difficult to recruit patients. It has been suggested that people would be more willing to take part in a study if they were better informed. It is possible to increase the number of questionnaires returned in the post, by sending information before the questionnaire is sent out. This study aims to find out if the number of people who agree to take part in the REFORM study can be increased by sending them a leaflet about the importance of research in the NHS, before theyre invited to take part in the study.
Who can participate?
Anyone who is approached to take part in the REFORM study
What does the study involve?
Some people are sent a leaflet to read before they are sent information about taking part in the REFORM study.
What are the possible benefits and risks of participating?
Whilst it cannot be promised that taking part in this study will help the participants, the information obtained may help to find how to increase the number of people taking part in research studies. No additional risks are expected.
Where is the study run from?
Podiatry clinics in North Yorkshire (UK)
When is the study starting and how long is it expected to run for?
Spring 2013 to Autumn 2013
Who is funding the study?
NIHR Health Technology Assessment Programme (HTA) (UK)
Who is the main contact?
Mrs Sarah Cockayne
sarah.cockayne@york.ac.uk
Study website
Contact information
Type
Scientific
Contact name
Prof David Torgerson
ORCID ID
http://orcid.org/0000-0002-1667-4275
Contact details
University of York
Department of Health Sciences
York Trials Unit
ARRC Building - Lower Ground Floor
Heslington
York
YO10 5 DD
United Kingdom
+44 (0)190 432 1340
david.torgerson@york.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
HTA 09/77/01
Study information
Scientific title
Randomised trial of a multifaceted podiatry intervention for fall prevention in patients over 65 years of age
Acronym
REFORM
Study hypothesis
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.
More details can be found at: https://www.journalslibrary.nihr.ac.uk/programmes/hta/097701/#/
Ethics approval(s)
1. NRES committee - East of England - Cambridge East, 09/11/2011
2. NRES committee - East of England - Cambridge East approved the Participant Information Sheet sub-study on 21/02/2013
3. 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 28/03/2013
Study design
Main REFORM study: Cohort randomised controlled trial including prospective economic evaluation and a qualitative sub-study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
GP practice
Study type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Falls prevention in older people
Intervention
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.
Intervention type
Other
Primary outcome measure
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.
Overall study start date
01/10/2011
Overall study end date
01/04/2015
Reason abandoned (if study stopped)
Eligibility
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 type(s)
Patient
Age group
Senior
Sex
Both
Target number of participants
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
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
Recruitment start date
01/10/2011
Recruitment end date
01/04/2015
Locations
Countries of recruitment
Ireland, United Kingdom
Study participating centre
University of York
York
YO10 5 DD
United Kingdom
Sponsor information
Organisation
University of York (UK)
Sponsor details
Research Innovation Office
York Science Park
Heslington
York
YO10 5DG
England
United Kingdom
+44 (0)190 443 5154
sue.final@york.ac.uk
Sponsor type
University/education
Website
ROR
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 17/12/2014 | Yes | No | |
| Results article | results | 20/01/2017 | Yes | No | |
| Results article | results | 28/03/2017 | Yes | No | |
| Results article | results | 01/04/2017 | Yes | No | |
| Results article | qualitative results | 21/04/2020 | 23/04/2020 | Yes | No |