Skip to main content
OpenTrials
Completed

NCT Number: NCT04598659

Nene Remote Monitoring Proof of Concept

This feasibility study is being conducted to investigate the practicalities and potential benefits of equipping patients with wearable monitoring devices.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northampton General Hospital

Northampton, United Kingdom

About this study

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:

  • Is it possible in principle to use the information captured from the devices to improve the treatment of the patient?
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Patient compliance

    Time frame: 7 days (the monitoring period)

    The percentage of all participating patients for whom a complete and unbroken record of their vital signs is obtained throughout the duration of the agreed monitoring period.

Secondary outcomes

  1. Device comfort assessed by a 5-point rating scale

    Time frame: 15 minutes

    Participants will be asked to rate how comfortable they found the device to wear during a telephone administered exit interview.

  2. Convenience of remote monitoring assessed by a 5-point rating scale

    Time frame: 15 minutes

    Participants will be asked how the remote monitoring device affected their daily routine during a telephone administered exit interview. Responses will be collected using a 5-point rating scale of convenience.

  3. The average time required to support patients through the remote monitoring process

    Time frame: 6 months

    The amount of time that the study team spends on-boarding patients (fitting the devices and explaining how they work) and supporting patients to use the devices will be recorded, to calculate the average time that staff will need to support each patient and estimate the resource requirement for implementing remote monitoring.

Sponsors and collaborators

Lead sponsor

Doccla UK

Industry

Collaborators

  • NHS Nene Clinical Commissioning Group
  • Northampton General Hospital NHS Trust

Registry information

Official study title

NHS England Proof of Concept - Smart Tech - Nene CCG

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 22, 2020
Registry last updated
Jan 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.