REducing Falls in IN-patient Elderly
| ISRCTN | ISRCTN44972300 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44972300 |
| Secondary identifying numbers | UKCRN 4527 |
- Submission date
- 17/08/2009
- Registration date
- 19/08/2009
- Last edited
- 23/10/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Opinder Sahota
Scientific
Scientific
Professor in Orthogeriatric Medicine & Consultant Physician
Queens Medical Centre
Nottingham University Hospitals NHS Trust
Nottingham
NG7 2UH
United Kingdom
| Phone | +44 (0)115 9249924 |
|---|---|
| opinder.sahota@nuh.nhs.uk |
Study information
| Study design | Interventional single centre parallel-arm randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | REducing Falls in IN-patient Elderly: a randomised controlled trial |
| Study acronym | REFINE |
| Study objectives | The use of a pressure sensor alert system, incorporating a radio-paging alerting mode to alert staff to patients rising from their bed or chair, can decrease the number of bedside falls, in older people hospitalised in an acute care setting. |
| Ethics approval(s) | Nottingham Research Ethics Committee 1 approved on the 23rd May 2008 (ref: 07HC006; MREC No.: 08/H0403/40) |
| Health condition(s) or problem(s) studied | Fall prevention |
| Intervention | Subjects are randomised either to receive bed and chair sensor equipment, or standard care (control arm). Subjects are allocated to the sensor or control arm using the web based randomisation service provided by the Clinical Trials Support Unit, University of Nottingham. The intervention is for the duration of the patient's ward admission, and the follow-up assessment is carried out one day prior, or on the day of, discharge. |
| Intervention type | Other |
| Primary outcome measure | Number of bedside in-patient falls per 1,000 bed days from time of randomisation until the participant is discharged from the ward. A bedside fall is defined as an unexpected event in which the participant comes to rest on the ground, floor or lower level in the area around the bedside, with the bedside being defined as the area encompassed by the curtained area surrounding the bed. Outcomes are measured one day prior, or on the day of, discharge. |
| Secondary outcome measures | Outcomes are measured one day prior, or on the day of, discharge: 1. Number of injurious in-patient falls per 1,000 bed days, defined as falls resulting in abrasion, bruise, swelling, cut, laceration, dislocation, fracture or muscle sprain or strain 2. Length of hospital stay 3. Residential status on discharge 4. Transfer/mobility score and activities of daily living, measured using the Barthel Index 5. Fear of falling, measured using the Modified Falls Efficacy Scale (mFES) to ascertain any differential fear of falling in the two participant groups due to an increased awareness of a potential for a fall, or a greater sense of safety arising from sensor use 6. Health related quality of life, measured using the EUROQOL EQ-5D |
| Overall study start date | 28/10/2008 |
| Completion date | 31/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 1800 |
| Key inclusion criteria | 1. In-patients 2. Male and female 3. Elderly, i.e., aged 65 years and over |
| Key exclusion criteria | 1. Permanently bed bound prior to admission 2. Moribund/unconscious 3. Receiving end of life care on admission 4. Previously been included in the study in an earlier admission |
| Date of first enrolment | 28/10/2008 |
| Date of final enrolment | 31/01/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Professor in Orthogeriatric Medicine & Consultant Physician
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Sponsor information
Nottingham University Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
England
United Kingdom
| Phone | +44 (0)115 9249924 |
|---|---|
| maria.koufali@nuh.nhs.uk | |
| Website | http://www.qmc.nhs.uk/ |
"ROR" |
https://ror.org/05y3qh794 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) (ref: PB-PG-0107-11112)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 10/09/2009 | Yes | No | |
| Results article | results | 01/03/2014 | Yes | No |
