Condition category
Injury, Occupational Diseases, Poisoning
Date applied
02/02/2010
Date assigned
13/04/2010
Last edited
15/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Falls and fractures are common and serious health problems for older people. A large study is needed to find out which types of treatments are most effective at preventing falls; whether they reduce fractures as well as falls; whether the treatments have effects on other problems that occur alongside or are linked to falls; and whether the treatments work best in people who are fitter or those who are frail. Because falls are a very common problem, we need to find out how acceptable the treatments are, and if people will naturally be more attracted to some types of treatments than others. We have designed a study that is able to answer these questions.

Who can participate?
Patients aged over 70 who are living in the community or in sheltered accommodation

What does the study involve?
Participating practices are randomly allocated to deliver one of following three falls prevention interventions to their patients: either advice only, advice with exercise, or advice with multifactorial falls prevention (MFFP). Patients are followed up for 18 months.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
The University of Warwick (UK)

When is the study starting and how long is it expected to run for?
June 2010 to May 2015

Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK)

Who is the main contact?
Prof Sarah Lamb
s.lamb@warwick.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Sarah Lamb

ORCID ID

Contact details

Warwick Clinical Trials Unit
The University of Warwick
Gibbet Hill Campus
Coventry
CV4 7AL
United Kingdom
+44 (0)24 7615 0404
s.lamb@warwick.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 08/14/41

Study information

Scientific title

Prevention of Fall Injury Trial: a parallel group cluster randomised controlled trial and economic evaluation

Acronym

Pre-FIT

Study hypothesis

The primary objective is to determine the comparative effectiveness of advice, exercise and a multi-factorial fall prevention (MFFP) programme on peripheral fractures among older people living in the community.

Further details can be found at: http://www.nets.nihr.ac.uk/projects/hta/081441

Ethics approval

Not provided at time of registration

Study design

Three-arm cluster-randomised controlled trial and economic evaluation

Primary study design

Interventional

Secondary study design

Cluster randomised 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

Fall-related injuries

Intervention

Three arms:
1. Written advice
2. Written advice plus structured exercise
3. Written advice plus multi-factorial fall prevention (MFFP)

The total duration of follow-up for all trial arms is 18 months (updated 13/08/2015: was previously 12 months). The total duration of treatment varies across trial arms as follows:
1. Advice: 30 minutes
2. Exercise: 12 weeks (two 1-hour sessions per week)
3. MFFP: 8 weeks (depending on individual risk factors, but typically six 30-minute sessions over 8 weeks)

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Peripheral fracture, data will be collected at 4, 8 and 12 months.

Secondary outcome measures

1. Time to first fracture
2. Falls rate per person years of observation
3. Health related quality of life
4. Mortality
Data will be collected at 4, 8 and 12 months.

Overall trial start date

01/06/2010

Overall trial end date

01/05/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Registered with a collaborating practice
2. Aged over 70 years, either sex
3. Living in the community, either alone, or with family/relative, friend or carer, or in sheltered accomodation

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

9000

Participant exclusion criteria

Patients living in residential nursing/care homes

Recruitment start date

01/06/2010

Recruitment end date

01/05/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The University of Warwick
Coventry
CV4 7AL
United Kingdom

Sponsor information

Organisation

University of Warwick (UK)

Sponsor details

University House
Kirby Corner Road
Coventry
CV4 8UW
United Kingdom

Sponsor type

University/education

Website

http://www2.warwick.ac.uk/services/rss/

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

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

01/09/2018

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26781504

Publication citations

Additional files

Editorial Notes

15/04/2016: Plain English summary added. 20/01/2016: Publication reference added.