Condition category
Injury, Occupational Diseases, Poisoning
Date applied
30/06/2011
Date assigned
01/07/2011
Last edited
23/07/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 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 the 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

Sub-studies added on 21/08/2013:

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 will be sent one of three information sheets and asked to fill in a questionnaire about the information they received.

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 provide better information to potential trial participants.

Where is the study run from?
We will be recruiting participants from podiatry clinics in England, in the Harrogate, Leeds, Scarborough, Sheffield and North Yorkshire areas.

When is the study starting and how long is it expected to run for?
The study will run from Spring 2013 and end in Autumn 2013.

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

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 they’re 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 will be 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?
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 may help us find out how we can increase the number of people taking part in research studies.

Where is the study run from?
We will be recruiting participants from podiatry clinics in England, North Yorkshire.

When is the study starting and how long is it expected to run for?
The study will run from Spring 2013 and end in Autumn 2013.

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof David Torgerson

ORCID ID

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 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.


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

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.

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

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below 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

Phase

Not Applicable

Drug names

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.

Overall trial start date

01/10/2011

Overall trial end date

01/04/2015

Reason abandoned

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

Patient

Age group

Senior

Gender

Both

Target number of participants

Main REFORM study: 1700 in the cohort and 890 in the randomised controlled trial.

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

Trial 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
United Kingdom
+44 (0)190 443 5154
sue.final@york.ac.uk

Sponsor type

University/education

Website

http://www.york.ac.uk

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK) (09/77/01)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25518875

Publication citations

Additional files

Editorial Notes