Ignite Creation Date:
2025-12-24 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 7:57 AM
Study NCT ID:
NCT04598659
Status:
COMPLETED
Last Update Posted:
2024-01-29
First Post:
2020-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nene Remote Monitoring Proof of Concept
Sponsor:
Doccla UK
Organization:
Study Overview
Official Title:
NHS England Proof of Concept - Smart Tech - Nene CCG
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This feasibility study is being conducted to investigate the practicalities and potential benefits of equipping patients with wearable monitoring devices.
Detailed Description:
Vital signs are important indicators used in healthcare to inform a patient's treatment options and care plan. However, the opportunity to monitor vital signs is largely limited to the time a patient spends at a healthcare providers premises. This study is being conducted to see if the use of small wearable monitoring devices could help deliver a better service and improve patient care by continuing to monitor patients remotely.
The study is observational and has been designed to address two key questions:
1. Is it possible in principle to use the information captured from the devices to improve the treatment of the patient?
2. How practical is it to implement remote patient monitoring (RPM)?
To address these questions, consenting patients will be asked to wear a small adhesive biosensor for a short period of time following discharge from hospital (either as an outpatient or inpatient).
The data gathered by the device will be examined retrospectively and patients will not be monitored in real-time. Following the monitoring period, the vital signs data captured by the device will be analysed to see if it correlates with any unscheduled healthcare needs (such as unplanned GP appointments or emergency hospital visits). Specifically, the study team will be investigating whether the monitoring could have picked up a nascent problem before it became more serious, or whether monitoring could have saved the patient from having to make a trip to see their GP.
Information regarding the practicalities of implementing RPM will be captured by monitoring compliance and through an exit interview with participating patients.
The study is observational and has been designed to address two key questions:
1. Is it possible in principle to use the information captured from the devices to improve the treatment of the patient?
2. How practical is it to implement remote patient monitoring (RPM)?
To address these questions, consenting patients will be asked to wear a small adhesive biosensor for a short period of time following discharge from hospital (either as an outpatient or inpatient).
The data gathered by the device will be examined retrospectively and patients will not be monitored in real-time. Following the monitoring period, the vital signs data captured by the device will be analysed to see if it correlates with any unscheduled healthcare needs (such as unplanned GP appointments or emergency hospital visits). Specifically, the study team will be investigating whether the monitoring could have picked up a nascent problem before it became more serious, or whether monitoring could have saved the patient from having to make a trip to see their GP.
Information regarding the practicalities of implementing RPM will be captured by monitoring compliance and through an exit interview with participating patients.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: