Condition category
Signs and Symptoms
Date applied
17/08/2009
Date assigned
19/08/2009
Last edited
23/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.qmc.nhs.uk/

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

Results - basic reporting

Publication summary

2009 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19744323
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24141253

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes