REducing Falls in IN-patient Elderly

ISRCTN	ISRCTN44972300
DOI	https://doi.org/10.1186/ISRCTN44972300
Protocol serial number	UKCRN 4527
Sponsor	Nottingham University Hospitals NHS Trust (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) (ref: PB-PG-0107-11112)

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

Professor in Orthogeriatric Medicine & Consultant Physician
Queens Medical Centre
Nottingham University Hospitals NHS Trust
Nottingham
NG7 2UH
United Kingdom

Phone	+44 (0)115 9249924
Email	opinder.sahota@nuh.nhs.uk

Study information

Primary study design	Interventional
Study design	Interventional single centre parallel-arm randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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
Completion date	31/01/2011

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Professor in Orthogeriatric Medicine & Consultant Physician

Nottingham
NG7 2UH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2014		Yes	No
Protocol article	protocol	10/09/2009		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes