Heart FailureNCT04598659
Nene Remote Monitoring Proof of Concept
An observational study of Heart Failure and Cardiovascular Diseases, run by Doccla UK at 1 site in United Kingdom.
Trial summary
This feasibility study is being conducted to investigate the practicalities and potential benefits of equipping patients with wearable monitoring devices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cardiovascular Diseases, Respiratory Disease
- How many people
- 180 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jan 2021to 6 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NHS England Proof of Concept - Smart Tech - Nene CCG
This feasibility study is being conducted to investigate the practicalities and potential benefits of equipping patients with wearable monitoring devices.
Read the 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:
- 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.
- Conditions
- Heart Failure, Cardiovascular Diseases, Respiratory Disease, Stroke
- Medical subject headings
- Heart Failure, Cardiovascular Diseases, Respiration Disorders, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days (the monitoring period)
Secondary outcomes (3)
Device comfort assessed by a 5-point rating scale
Participants will be asked to rate how comfortable they found the device to wear during a telephone administered exit interview.
Measured: 15 minutes
Convenience of remote monitoring assessed by a 5-point rating scale
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.
Measured: 15 minutes
The average time required to support patients through the remote monitoring process
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start6 Jan 2021
- Primary completion6 Jan 2022
- Study completion6 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Doccla UK
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NHS Nene Clinical Commissioning Group, Northampton General Hospital NHS Trust
- Responsible party
- Principal investigator, Denis Shaughnessy, Doccla UK
- Investigators
- David Sharman, Principal investigator, Northampton General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598659
- Sponsor's protocol ID
- NPoC1
- Status last verified
- Jan 2024
- First submitted
- 16 Oct 2020
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NHS England Proof of Concept - Smart Tech - Nene CCG
- ClinicalTrials.gov ID
- NCT04598659
- Acronym / sponsor ID
- NPoC1
- Conditions
- Heart Failure, Cardiovascular Diseases, Respiratory Disease, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Doccla UKIndustry (pharma, biotech, devices)
- Collaborators
- NHS Nene Clinical Commissioning Group, Northampton General Hospital NHS Trust
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 6 Jan 2022 (actual)
- Study completion
- 6 Mar 2022 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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),
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Device comfort assessed by a 5-point rating scale
Time frame: 15 minutes
Convenience of remote monitoring assessed by a 5-point rating scale
Time frame: 15 minutes
The average time required to support patients through the remote monitoring process
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Sharman principal investigator
Northampton General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Cardiovascular Diseases, run by Doccla UK at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient compliance (time frame: 7 days (the monitoring period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.