Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
30 participants
OBSERVATIONAL
2023-04-05
2023-09-30
Brief Summary
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Detailed Description
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Accordingly, this study aims to investigate the accuracy and user-friendliness of new contactless technology to measure patients 'vital signs', paving the way towards enabling home-based patients to independently measure their vital signs during their admission. Besides enabling increased frequency of routine monitoring, this technology can also be applied to improve ad hoc assessments when patients report clinical concerns by enabling vital signs to be remotely measured by patients and/or their carers whilst clinicians travel to their homes to deliver treatment. Results from publication of this study will add to lexicon of knowledge regarding the utility of remote monitoring devices in monitoring and detecting clinical deterioration amongst hospitalized patients at home.
In this two-stage study, participants' vital signs obtained by the new contactless sensor are first compared with standard vital sign measurements obtained by nursing staff on the hospital ward. Should the sensor be found to obtain similar measurements thus indicating accuracy and feasibility of use amongst hospital patients, the second stage of this study involves investigating the feasibility of participants utilising these devices to measure their vital signs in the home-setting.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Hospitalised inpatients
Ten patients admitted into the Acute Care of the Elderly (ACE) ward will be approached for inclusion in the study. Patients will be given written information about the trial. Nursing staff looking after these patients will be asked to utilise the device after vital sign measurements obtained from standard hospital equipment when conducting routine vital sign measurements. Nurses will do this for the duration of the admission of 7days, thus generating 28 paired data points for comparison.
Validation of the accuracy of a combined oximeter, thermometer and heart rate measurement device
Validation of the combined device measurements compared with standard of care devices
Inpatients at home
Fifteen patients admitted into the home-based ward would be approached for inclusion in the study. Participants will undergo a 20 minute education session then be supplied with the device, companion app (user interface) on a mobile tablet, and written information about the trial.
Participants will be asked to measure their vital signs four times a day, with one of those measurements occurring immediately after the clinical nurse' home review using standard hospital equipment for vital sign measurements (this matched pair of vital signs measurements will be taken as reference). Participants will do this for at least 7 days, thus generating 7 matched data points for comparison against reference, and 21 data points where participants independently conducted vital signs measurements with the Norbert sensor.
Validation of the accuracy of a combined oximeter, thermometer and heart rate measurement device
Validation of the combined device measurements compared with standard of care devices
Interventions
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Validation of the accuracy of a combined oximeter, thermometer and heart rate measurement device
Validation of the combined device measurements compared with standard of care devices
Eligibility Criteria
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Inclusion Criteria
* Patients expected to remain admitted within the two wards over 7 days of the study for availability of their vital sign measurements
* technological capability to utilise the device's companion app, as evidenced by ownership and utilisation of a 'smart' device (eg smartphone)
Exclusion Criteria
* Clinical instability impeding participants' ability to independently conduct vital sign measurements
* Physical concerns (e.g. manual dexterity) impeding participants' ability to independently conduct vital sign measurements
* Environmental and technical issues such as lack of home Wi-Fi system, location of home in a 'Wi-Fi black spot', or unsafe home environments, that impede participants' ability to independently conduct vital sign measurements
18 Years
110 Years
ALL
No
Sponsors
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Melbourne Health
OTHER
Responsible Party
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Locations
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Royal Melbourne Hospital
Melbourne, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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Research Officer
Role: primary
Other Identifiers
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RMH89542
Identifier Type: -
Identifier Source: org_study_id
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