Prevention of Fall Injury Trial
| ISRCTN | ISRCTN71002650 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71002650 |
| Secondary identifying numbers | HTA 08/14/41 |
- Submission date
- 02/02/2010
- Registration date
- 13/04/2010
- Last edited
- 03/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
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 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
Contact information
Scientific
Warwick Clinical Trials Unit
The University of Warwick
Gibbet Hill Campus
Coventry
CV4 7AL
United Kingdom
| Phone | +44 (0)24 7615 0404 |
|---|---|
| sarah.lamb@ndorms.ox.ac.uk |
Study information
| Study design | Three-arm cluster-randomised controlled trial and economic evaluation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Prevention of Fall Injury Trial: a parallel group cluster randomised controlled trial and economic evaluation |
| Study acronym | Pre-FIT |
| Study hypothesis | 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 |
| Ethics approval(s) | Approved 29/04/2010, Derbyshire Research Ethics Committee (1 Standard Court, Park Row, Nottingham NG1 6GN, UK; +44 (0)115 8839461; lisa.gregory@nottspct.nhs.uk), REC ref: 10/H0401/36 |
| Condition | Fall-related injuries |
| 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 measure | 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. |
| Overall study start date | 01/06/2010 |
| Overall study end date | 28/02/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 9000 |
| Total final enrolment | 9803 |
| 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 |
| Recruitment start date | 01/06/2010 |
| Recruitment end date | 30/06/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
CV4 7AL
United Kingdom
Sponsor information
University/education
University House
Kirby Corner Road
Coventry
CV4 8UW
England
United Kingdom
| Website | http://www2.warwick.ac.uk/services/rss/ |
|---|---|
"ROR" |
https://ror.org/01a77tt86 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 28/03/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 18/01/2016 | Yes | No | |
| Results article | data collection method SWAT results | 01/02/2019 | 20/01/2020 | Yes | No |
| Results article | baseline results | 15/01/2020 | 12/11/2020 | Yes | No |
| Results article | results | 05/11/2020 | 26/11/2020 | Yes | No |
| Results article | 01/05/2021 | 03/06/2021 | Yes | No | |
| Results article | 23/01/2023 | 24/01/2023 | Yes | No | |
| Results article | 02/10/2023 | 03/10/2023 | Yes | No |
Editorial Notes
03/10/2023: Publication reference added.
24/01/2023: Publication reference added.
03/06/2021: Publication reference added.
26/11/2020: Publication reference added.
12/11/2020: Publication reference added.
28/04/2020: Ethics approval details added.
20/01/2020: Publication reference added.
18/04/2019: The study hypothesis was corrected.
28/03/2019: The following changes were made to the trial record:
1. The overall trial end date was changed from 01/09/2018 to 28/02/2019.
2. The intention to publish date was changed from 28/03/2019 to 28/03/2020.
3. The total final enrollment number was added.
18/04/2018: The following changes were made to the trial record:
1. The hypothesis, interventions, primary and secondary outcome measures, and inclusion and exclusion criteria were updated.
2. The recruitment end date was changed from 01/05/2015 to 30/6/2014.
3. The overall trial end date was changed from 01/05/2015 to 01/02/2019.
15/04/2016: Plain English summary added.
20/01/2016: Publication reference added.
