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Prevention of Fall Injury Trial | Not Recruiting
Prevention of Fall Injury Trial | Not Recruiting
Prevention of Fall Injury Trial
Pre-FIT

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Medical Conditions
  • Fall-related injuries
Primary Contact Details
Prof Sarah Lamb
+44 (0)24 7615 0404
See all trial contact details
Recruitment Status
Not Recruiting
Trial source and source ID number
ISRCTN71002650
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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 including sheltered or supported 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?
None

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 February 2019

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

Who is the main contact?
Prof Sarah Lamb
sarah.lamb@ndorms.ox.ac.uk
Research Details
  • Current study hypothesis as of 18/04/2018:
    The primary objective is to determine the comparative effectiveness of advice, exercise and a multi-factorial fall prevention (MFFP) programme on fractures among older people living in the community.

    Previous 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
Phase
Sorry, this information is not available
Study Design
Three-arm cluster-randomised controlled trial and economic evaluation
Study Type
Interventional
Intervention

Current interventions as of 18/04/2018:
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: Age Concern Staying Steady Advice Leaflet
2. Exercise: Age Concern Staying Steady Advice Leaflet together with upto 6 months of a physiotherapist supported home exercise programme
3. MFFP: Age Concern Staying Steady Advice Leaflet together with a single Multi-Factorial Falls Prevention Assessment, with onwards referral as necessary

Previous interventions:
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
Primary Outcome Measures
    Current primary outcome measures as of 18/04/2018:
    Fracture, data will be collected at 4, 8, 12 and 18 (updated 13/08/2015: was previously 12) months

    Previous primary outcome measures:
    Peripheral fracture, data will be collected at 4, 8 and 18 (updated 13/08/2015: was previously 12) months.
Secondary Outcome Measures
    Current secondary outcome measures as of 18/04/2018:
    1. Falls rate per person years of observation
    2. Health related quality of life
    3. Mortality
    Data will be collected at 4, 8, 12 and 18 (updated 13/08/2015: was previously 12) months.

    Previous 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 18 (updated 13/08/2015: was previously 12) months.
Publication(s)
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26781504
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Senior
Who Can Participate
Patient
Number of Participants
9000
Participant Inclusion Criteria
    Current inclusion criteria as of 18/04/2018:
    1. Registered with a collaborating practice
    2. Aged over 70 years
    3. Living in the community, including living in sheltered or supported accommodation
    4. Able to provided informed written consent

    Previous 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 Exclusion Criteria
    Current exclusion criteria as of 18/04/2018:
    1. Patients living in residential nursing/care homes
    2. Limited life expectancy (<6 months)
    3. Anything that in the GP’s opinion would place the patient at an increased risk or preclude full compliance or completion of the study

    Previous exclusion criteria:
    Patients living in residential nursing/care homes
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Coventry
CV4 7AL
Trial Contact(s)
Primary Trial Contact
Prof Sarah Lamb
+44 (0)24 7615 0404
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Prevention of Fall Injury Trial: a parallel group cluster randomised controlled trial and economic evaluation
EudraCT Number
Sorry, this information is not available
Funder(s)
  • Health Technology Assessment Programme
Other Study ID Numbers
HTA 08/14/41
Sponsor(s)
University of Warwick (UK)
Key Dates

Recruitment Start Date

01 Jun 2010

Recruitment End Date

30 Jun 2014

Trial Start Date

01 Jun 2010

Trial End Date

28 Feb 2019

Date added to source

13 Apr 2010

Date updated in source

18 Apr 2019