Contact information
Type
Scientific
Primary contact
Prof Opinder Sahota
ORCID ID
Contact details
Professor in Orthogeriatric Medicine & Consultant Physician
Queens Medical Centre
Nottingham University Hospitals NHS Trust
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 9249924
opinder.sahota@nuh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
UKCRN 4527
Study information
Scientific title
REducing Falls in IN-patient Elderly: a randomised controlled trial
Acronym
REFINE
Study hypothesis
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
Nottingham Research Ethics Committee 1 approved on the 23rd May 2008 (ref: 07HC006; MREC No.: 08/H0403/40)
Study design
Interventional single centre parallel-arm randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
28/10/2008
Overall trial end date
31/01/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. In-patients
2. Male and female
3. Elderly, i.e., aged 65 years and over
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
1800
Participant 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
Recruitment start date
28/10/2008
Recruitment end date
31/01/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Professor in Orthogeriatric Medicine & Consultant Physician
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Organisation
Nottingham University Hospitals NHS Trust (UK)
Sponsor details
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 9249924
maria.koufali@nuh.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) (ref: PB-PG-0107-11112)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19744323
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24141253
Publication citations
-
Protocol
Vass CD, Sahota O, Drummond A, Kendrick D, Gladman J, Sach T, Avis M, Grainge M, REFINE (Reducing Falls in In-patient Elderly)--a randomised controlled trial., Trials, 2009, 10, 83, doi: 10.1186/1745-6215-10-83.
-
Results
Sahota O, Drummond A, Kendrick D, Grainge MJ, Vass C, Sach T, Gladman J, Avis M, REFINE (REducing Falls in In-patieNt Elderly) using bed and bedside chair pressure sensors linked to radio-pagers in acute hospital care: a randomised controlled trial., Age Ageing, 2014, 43, 2, 247-253, doi: 10.1093/ageing/aft155.