Accidental FallSAFENCT03418103
System to Avoid Fall Events
An observational study of Accidental Fall, run by Rinicare Ltd.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Accidental Fall
- What is being tested?
- Thermal imaging analysis of participant position in a hospital bed
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 3 May 2018to 31 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients admitted to ward 20 at the Royal Lancaster Infirmary .
Who may be able to join
- 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:
- Frailty due to old age (E.g. 65 years or older)
- Frailty due to medical conditions (E.g. hypotension)
- Frailty due to mental conditions (E.g. dementia)
- Frailty due to physical conditions (E.g. amputation or injury)
- Frailty due to medication(s)
- Patients who are able to give informed consent will be included. In addition, any patients who are unable to consent to participation in this study due to a lack of mental capacity but are assessed by the ward matron to benefit from participation in this study will also be included. Where possible, consent will be obtained from close relatives or legal guardians in this case. 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.
Who cannot join
- Patients under 18 years of age Patients who are in an unconscious or comatose state, physically restrained to the bed, or otherwise completely unable to move under their own power and thus not at risk of falling out of their bed
Trial locations and contacts
No sites are listed yet.
About this study
Official title: System to Avoid Fall Events: A Descriptive Comparison Study Evaluating the Quantitative Impact of Using Thermal Imaging to Monitor At-risk Patients.
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.
- Conditions
- Accidental Fall
- Being tested
- Thermal imaging analysis of participant position in a hospital bed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal imaging analysis of participant position in a hospital bedDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of falls recorded
The number of falls and fall related incidents in the ward
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start3 May 2018 (estimated)
- Primary completion15 Aug 2018 (estimated)
- Study completion31 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rinicare Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospitals of Morecambe Bay NHS Trust
- Responsible party
- Sponsor
- Investigators
- Kim Wilson, BA (Hons), Principal investigator, University Hospitals of Morecambe Bay NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418103
- Sponsor's protocol ID
- 999
- Acronym
- SAFE
- Status last verified
- Jan 2018
- First submitted
- 25 Jan 2018
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- System to Avoid Fall Events: A Descriptive Comparison Study Evaluating the Quantitative Impact of Using Thermal Imaging to Monitor At-risk Patients.
- ClinicalTrials.gov ID
- NCT03418103
- Acronym / sponsor ID
- SAFE / 999
- Conditions
- Accidental Fall
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rinicare LtdIndustry (pharma, biotech, devices)
- Collaborators
- University Hospitals of Morecambe Bay NHS Trust
- Study start
- 3 May 2018 (estimated)
- Primary completion
- 15 Aug 2018 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 1 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to ward 20 at the Royal Lancaster Infirmary .
Key inclusion criteria (7 listed)
- 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:
- Frailty due to old age (E.g. 65 years or older)
- Frailty due to medical conditions (E.g. hypotension)
- Frailty due to mental conditions (E.g. dementia)
- Frailty due to physical conditions (E.g. amputation or injury)
Key exclusion criteria (1 listed)
- Patients under 18 years of age Patients who are in an unconscious or comatose state, physically restrained to the bed, or otherwise completely unable to move under their own power and thus not at risk of falling out of their bed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermal imaging analysis of participant position in a hospital bedThe 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. | Device | – |
Primary outcome
Number of falls recorded
Time frame: 12 months
The number of falls and fall related incidents in the ward
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Accidental Fall
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Effects of a Novel Perturbation Balance Training Program on Laboratory and Real-World Trip-Induced Losses of Balance and Falls Among Balance-Impaired Older Adults
Accidental Fall
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Whole-Body Point-of-Care Ultrasound in Older Adults Presenting to the Emergency Department After a Fall
Accidental Falls, Aged
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Preventing Loss of Independence Through Exercise in Community Living Centers
Dementia, Cognitive Dysfunction
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Turkish Adaptation of the Multidimensional Falls Efficacy Scale in Older Adults
Balance Control in Elderly, Falls (Accidents) in Old Age
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Wilson, BA (Hons) principal investigator
University Hospitals of Morecambe Bay NHS Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Accidental Fall, run by Rinicare Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Søren Udby, MSc (+44 1524840450, sudby@rinicare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of falls recorded (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018.