System to Avoid Fall Events
SAFE
SAFE
Sponsor study identifier
observational
50
0 countries
N/A
Study Start
May 3, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 15, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Rinicare Ltd, a Lancaster-based SME, and University Hospitals of Morecambe Bay Trust (UHMB) will collaborate on a research study to determine the feasibility, suitability, and acceptability of the Rinicare developed SAFE (System to Avoid Fall Events) fall prevention and detection system in a hospital environment. The study is designed to determine if the implementation of the SAFE system will help clinicians to prevent in-patient falls from hospital beds. In-patient falls are a serious problem with more than 245,000 incidents reports in 2015-2016. 77% of these falls involve a patient over the age of 65, and the injuries patients suffer due to falls is estimated by NICE to cost the NHS £2.3B annually. This study will test the performance of the SAFE technologies against the current interventions to prevent falls, and it will investigate the impact of the SAFE technology on the workflow of the carers. The SAFE study is designed as a comparison study combining a descriptive, quantitative methodology measuring the number of fall events with a normative analysis of the qualitative aspects experienced by the clinicians using the SAFE system during the project period. The primary research objective of this study is to determine if the implementation of the SAFE system will quantifiably reduce the number of fall events in the ward compared to a similar control period. The secondary research objective is to determine if the SAFE system has a positive or a negative impact on the ward staff's workflow, i.e. the ability of the ward staff to provide care to the patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 25, 2018
Actual (reported)February 1, 2018
Actual (reported)May 3, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 15, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Number of falls recorded
The number of falls and fall related incidents in the ward
12 months
The SAFE sensor system will use thermal imaging to detect and identify a participant's position relative to the edges of the hospital bed. If a dangerous position is identified, an alarm notification will be sent to the ward staff to allow them to take pre-emptive action to prevent the participant's situation from evolving into a fall event.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients admitted to ward 20 at the Royal Lancaster Infirmary .
Kim Wilson, BA (Hons)
University Hospitals of Morecambe Bay NHS Trust
First Submitted
January 25, 2018
First Posted
February 1, 2018
Study Start
May 3, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 15, 2018
Estimated (date passed)Accidental Falls Care Bundle
Effects of a Falls Prevention Program Following Hospital Discharge
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 11, 2018
Record last verified: 2018-01
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Source: ClinicalTrials.gov.
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