Clinical trial NCT04598659: Nene Remote Monitoring Proof of Concept
Official title: NHS England Proof of Concept - Smart Tech - Nene CCG
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Cardiovascular Diseases
Respiratory Disease
Stroke
Lead sponsor: Doccla UK
Sponsor class: INDUSTRY
Collaborators: name: NHS Nene Clinical Commissioning Group
name: Northampton General Hospital NHS Trust
First posted: 2020-10-22
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include patients who present themselves for care or consultation at the Northampton General Hospital during the period of the study.

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.

Eligibility criteria: Inclusion Criteria:

* The participant is able to provide informed consent.
* The participant is able to comply with the English instructions for using a wearable device (e.g, follow simple instructions, able to answer the telephone, able to answer symptom questions, etc.).
* The participant may have been recently discharged from a hospital care setting (including emergency departments, ward and acute assessment units) to home (including a relative's home) or be currently admitted to a hospital care setting.
* The participant has a recent medical history that suggests there is a risk their health may deteriorate at home. In the first instance we will focus upon patients with at least one of the following conditions:
* Heart Failure (the patient being discharged),
* Arrhythmia (e.g. patient on the waitlist for a pacemaker)
* We will also consider patients with other conditions that present a risk of deterioration at home, for example: COPD, stable angina, liver failure, minor trauma, chronic kidney disease, stroke, hypertension, cancer ( e.g. recent surgery)

Exclusion Criteria:

* Patients that are clinically unstable (eg: respiratory distress, ongoing angina pectoris, sepsis, etc).
* Aphasia or other conditions that prevents the patient from adequately communicating with the researchers.
* Terminal diagnosis with life expectancy \< 3 months.
* Ongoing renal dialysis, or other treatment that prevents the patient from being at home for extended periods.
* Dementia or uncontrolled psychiatric illness.
* Severe dermatitis or another skin disorder that prevents the patient from wearing a patch.
* Patient has a pacemaker or ICD
* Other inability, or unwillingness, to adequately co-operate with the RPM-team.

Primary outcomes:
measure: Patient compliance
timeFrame: 7 days (the monitoring period)
Secondary outcomes:
measure: Device comfort assessed by a 5-point rating scale
timeFrame: 15 minutes
measure: Convenience of remote monitoring assessed by a 5-point rating scale
timeFrame: 15 minutes
measure: The average time required to support patients through the remote monitoring process
timeFrame: 6 months
Other outcomes:
Locations:
city: Northampton
country: United Kingdom
facility: Northampton General Hospital
Study officials:
affiliation: Northampton General Hospital
name: David Sharman
role: PRINCIPAL_INVESTIGATOR
References: