Nene Remote Monitoring Proof of Concept

NCT04598659 | Completed

• 1 other identifier: NPoC1
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure; Cardiovascular Diseases; Respiratory Disease; Stroke

Outcome Measures

Primary Outcomes (1)

• Patient compliance

  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.

  7 days (the monitoring period)

Secondary Outcomes (3)

• Device comfort assessed by a 5-point rating scale

  15 minutes

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

  15 minutes

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

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Doccla UK: lead
• NHS Nene Clinical Commissioning Group: collaborator
• Northampton General Hospital NHS Trust: collaborator

Study Sites (1)

Northampton General Hospital

Northampton, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure; Cardiovascular Diseases; Respiration Disorders; Stroke

Condition Hierarchy (Ancestors)

Heart Diseases; Respiratory Tract Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• David Sharman

  Northampton General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: October 22, 2020
• Study Start: January 6, 2021
• Primary Completion: January 6, 2022
• Study Completion: March 6, 2022
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)