Condition category
Injury, Occupational Diseases, Poisoning
Date applied
04/01/2018
Date assigned
25/01/2018
Last edited
25/01/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In-patient falls are the most commonly reported patient safety issue in the NHS. Elderly, frail patients are at a particularly high risk of suffering a fall while admitted to hospital. In 2015/2015, more than 247,000 patients suffered an in-patient fall event with more than 10,500 patients over the age of 65 suffered severe harm as the result of a fall. The combined cost to the NHS is £150 million just for this type of injuries. Therefore, this study aims to test a new technology to provide nurses and clinicians with an early warning of situations that are known to frequently cause falls.

Who can participate?
Patients admitted to the ward who are deemed by the ward clinicians to be at risk of falling from the bed

What does the study involve?
The technology uses a non-invasive thermal sensor to measure the patient's position inside the bed. When a patient moves to exit the bed, a notification is sent to a ward nurse, who can respond appropriately to the situation. Should a patient fall out of bed and onto the floor, the technology raises an alarm to the nurses. The study compares the number of fall events recorded in a control phase without the technology with the number of fall events recorded during a test phase with the technology. Each phase lasts 3 months, with a 3-month follow-up.

What are the possible benefits and risks of participating?
The benefit of the study is that the technology may enable nurses to potentially take pre-emptive action before a fall occurs rather than react when a fall has already happened. No direct risk to the participants has been identified. All the hardware is installed after stringent safety precautions to eliminate risks of both voluntary and involuntary misuse of the system during the study.

Where is the study run from?
Royal Lancaster Infirmary (UK)

When is the study starting and how long is it expected to run for?
January 2018 to November 2018

Who is funding the study?
Rinicare Ltd (UK)

Who is the main contact?
1. Søren Udby (public)
2. Margaret Cooper (scientific)

Trial website

Contact information

Type

Public

Primary contact

Mr Søren Udby

ORCID ID

http://orcid.org/0000-0001-8711-2168

Contact details

Riverway House
Morecambe Road
Lancaster
LA1 2RX
United Kingdom

Type

Scientific

Additional contact

Mrs Margaret Cooper

ORCID ID

http://orcid.org/0000-0001-9103-6639

Contact details

Ashton Road
Lancaster
LA1 4RP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

999

Study information

Scientific title

An investigation to explore the feasibility of thermal imaging technology to prevent frail, elderly, and vulnerable patients in hospital wards from suffering preventable, in-patient fall events causing moderate to severe damage

Acronym

SAFE

Study hypothesis

The study aims to determine the feasibility, suitability, and acceptability of using thermal imaging analysis to produce early warning notifications to prevent at-risk patients from suffering a fall from a bed while in hospital.

Ethics approval

Not provided at time of registration

Study design

Interventional non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Patients deemed to be at risk of suffering a fall from a bed due to physical frailty, medication, or mental issues

Intervention

The participants will have a SAFE sensor system installed above their hospital bed as part of this study. The SAFE sensor unit will monitor the participant's position relative to the edge of the bed in real-time. If a dangerous situation is detected by the system, e.g. a frail, elderly patient sitting on the edge of the bed in preparation to exit the bed, the SAFE system will notify a member of the ward staff to inform them of the situation and take appropriate actions to ensure that the patient exits the bed safely.

The study will compare the number of fall events recorded in a control phase with the number of fall events recorded during the test phase. Each phase is planned for 3 months, with a 3-month follow-up.

Intervention type

Device

Phase

Drug names

Primary outcome measure

The number of fall events recorded during the test phase and the control phase

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

29/01/2018

Overall trial end date

19/11/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients admitted to the ward for a duration of no less than 48 hours
2. Patients who are deemed by the ward clinicians to be at risk of falling from the bed due to one or more of the following reasons:
2.1. Frailty due to old age (e.g. 65 years or older)
2.2. Frailty due to medical conditions (e.g. hypotension)
2.3. Frailty due to mental conditions (e.g. dementia)
2.4. Frailty due to physical conditions (e.g. amputation)
2.5. Frailty due to medication(s)
Patients who are able to give informed consent or individuals unable to consent to participation due to a lack of mental capacity their participation needs to be agreed by someone who is independent of the study and who can assess the potential participant’s interests in accordance with current legislation and guidance.

This person may be a relative, a carer or an independent representative. These patients are a particularly vulnerable group and their interests must therefore be protected. They should be given the same opportunities to participate in ethically designed research projects as those who do not lack capacity but must not be put at unwarranted risk.

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

90

Participant exclusion criteria

1. Patients under 18 years of age
2. Patients in an unconscious state or otherwise unable to move under the own power

Recruitment start date

02/03/2018

Recruitment end date

15/08/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Lancaster Infirmary
Ashton Road
Lancaster
LA1 4RP
United Kingdom

Sponsor information

Organisation

Rinicare Ltd

Sponsor details

Riverway Hourse
Morecambe Road
Lancaster
LA1 2RX
United Kingdom

Sponsor type

Industry

Website

www.rinicare.com

Funders

Funder type

Industry

Funder name

Rinicare Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. A number of supporting documents have been prepared for this trial:
1.1. The study protocol, currently under review from senior management (due back on Monday 15/01/2018)
1.2. Participant consent form
1.3. Participant information sheet
1.4. Consultee information sheet
1.5. Participant data privacy and protection protocol (in compliance with Rinicare’s internal ISO27001 protocols)
1.6. A paper is planned to be published after the completion of the trial for a peer-reviewed journal
2. The plan is to set-up a sub-site for the trial on the www.rinicare.com website with all the publicly available documents.

The intention is to publish an article for a relevant peer-reviewed journal within 3 months of the conclusion of the study. Furthermore, the outcome of the study will be published on Rinicare's website.

IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository.

Intention to publish date

19/02/2019

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes