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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06043986
Other study ID # CD22/153868
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 23, 2023
Est. completion date September 2, 2024

Study information

Verified date October 2023
Source The Leeds Teaching Hospitals NHS Trust
Contact Lucy Leese
Phone 0113 2065455
Email l.leese@nhs.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patients are admitted to wards at all times of day and night and in various states of ill health. As this research is non interventional and does not impact on patient safety, the guidance from the ethics committee was reviewed and agreed that it would be appropriate to enrol every admission into the 2 bed bays and gain consent within 24 hours of admission.All data collected within the trial using the smart tablets will be associated to a study number, no patient details will be stored on the smart tablet and therefore the cloud data store.It has been discussed with the trust information governance and this complies with their regulations. Any patient identifiable data will be kept by the research team. All data will be archived and stored as per the Sponsors policy. The novel nurse call system has been designed to be user friendly to all patients regardless of age, learning ability and first language used. By using colours, images and words in the hope that this will be accessible to all. The nursing staff on the ward advised on the main reasons for the nurse call system activation and therefore the icons used in the novel system were adapted from this. This trial was discussed in the patient and public involvement group. As this is a pilot trial, any adaptions that need to be made will be made before the large scale trial.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date September 2, 2024
Est. primary completion date September 2, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: All adults 18 years who are admitted to the cardiology admissions ward will be eligible to take part. - Exclusion Criteria: Any patient who does not wish to participate will have their anonymised data removed from the trial. -

Study Design


Related Conditions & MeSH terms


Intervention

Device:
novel nurse call system
Inavya Ventures Ltd (Inavya) has developed a medical-grade artificial intelligence enabled mobile system (AVATR) to support out-of-hospital healthcare. AVATR is approved as a UK Government official supplier of healthcare technology on the UK Digital Marketplace for cloud-based solutions (G Cloud). AVATR in hospital, will connect to the existing AVATR outpatient service building on existing AVATR technology, which is regulated CE-mark Grade 1 (EU/UK). The research team will create, deploy and test a novel ward-based AI technology innovation to transform current nurse call systems to patient-centred mobile technology assets at bedside, thus reducing the need for unproductive visits by nurses to the bedside, which takes away time and attention where it is otherwise best served. Having mobile connection to the patients, would improve patient experience and saving nursing staff time, thereby improving quality of care, and saving money.

Locations

Country Name City State
United Kingdom Leeds Teaching Hospital NHS Trust Leeds

Sponsors (1)

Lead Sponsor Collaborator
The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary study objective The primary outcome of this study is the time taken to respond to the alert raised by the novel nurse call system and time taken from call to completion of task. 1 year
Secondary Nursing time saved The time taken using the novel system will be measured against the regular method to find the difference in time. 1 year
Secondary patient acceptability of the novel system this is a qualitative measure 1 year
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