Medical EmergenciesFUSENCT06199310
FUSE - Feasibility of Patient Held Sensors for Medical Emergencies
An observational study of Medical Emergencies, run by Betsi Cadwaladr University Health Board at 1 site in United Kingdom.
Trial summary
The investigators want to study how wearable devices can help track health changes in people when they are not feeling well. Normally, clinicians compare someone's vital signs, like heart rate, to average ranges from healthy folks. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Medical Emergencies
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jun 2023to 1 Dec 2024
- How long will I take part?
- 1 Day
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients presenting to hospital with a medical condition / complaint.
Who may be able to join
- A subject must meet all the following criteria:
- Have an acute presenting complaint
- Aged 18 years or older
- Uses any of the following: smart-watch, activity tracker, or other wearable monitoring device, a smart phone that collects data from other wearable device
- Ability to give informed consent
Who cannot join
- Unable to give informed consent, including patients with immediately life-threatening illness
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Ysbyty Gwynedd
Bangor, LL57 2PW
Christian Subbe, DM, +447771922890, c.subbe@bangor.ac.uk
csubbe@hotmail.com
About this study
Official title: Feasibility of Using Resting Heart Rate and Step-counts From Patient-held Sensors During Clinical Assessment of Medical Emergencies (FUSE)
The investigators want to study how wearable devices can help track health changes in people when they are not feeling well. Normally, clinicians compare someone's vital signs, like heart rate, to average ranges from healthy folks. But what if clinicians compare these signs to the person's own normal when they were well? The investigators aim to check if wearable sensors can make this possible for many people. The investigators will look at heart rate differences when someone is admitted to the hospital compared to their stable days before. The investigators will see how their daily steps change a week before getting sick. This global study involves adults in emergency or acute care. Participation poses no risks, burdens, or immediate benefits to patients.
Read the detailed description
Rationale:
Abnormalities of vital signs are quantified by comparison with 'usual' ranges, which are those observed in resting healthy populations. It might be more appropriate to compare vital sign values of an individual that is in distress with their own usual values recorded when they were stable and well. Wearable sensors might make this possible at scale.
Objectives:
- To quantify the difference between heart rate on admission to acute care compared to the previously recorded vital signs when 24 hours and 1 week prior of the same patient.
- The change in daily steps taken by the patient in the week prior to admission to acute care
- To assess the feasibility of using heart rate data from patients' own wearable sensors.
Study design:
An asynchronous, international, multicentre observational study using the Flash Mob Research design.
Study population:
Patients aged 18 years and up who present at the Emergency Department, Acute Medical Department or Ambulatory Emergency Care with an acute complaint.
Main study parameters/endpoints:
- The difference between heart rate measured on presentation to acute care services, and measured prior when stable and well.
- The daily number of steps taken in the week prior to presentation to acute care services.
- The proportion of patients assessed for an acute complaint who have recordings of vital signs measured before they became unwell.
- A description of the population that uses devices that collect vital signs in terms of sex, age-group, digital literacy, and their severity of illness on presentation (as measured by a standard set of vital signs and frailty).
- The devices used to measure vital signs before they became unwell, and the vital signs they measure.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
There is no burden or risk associated with participation to patients, and no immediate benefit.
- Conditions
- Medical Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital admission
Proportion of patients admitted to hospital
Measured: Within 24 hours of assessment
Secondary outcomes (2)
Change in heart rate
Trends in heart rate (beats per minute) prior to admission to hospital
Measured: 1 week (+/- 1 day)
Change in step count
Trends in step count (daily steps) in the week prior to admission to hospital
Measured: 1 week (+/- 1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start30 Jun 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical EmergenciesStudies 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
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Betsi Cadwaladr University Health Board
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Christian P Subbe, Betsi Cadwaladr University Health Board
- Investigators
- Christian Subbe, Principal investigator, YSBYTY Gwynedd Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199310
- Sponsor's protocol ID
- IRAS 321129
- Acronym
- FUSE
- Status last verified
- Dec 2023
- First submitted
- 3 Dec 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Using Resting Heart Rate and Step-counts From Patient-held Sensors During Clinical Assessment of Medical Emergencies (FUSE)
- ClinicalTrials.gov ID
- NCT06199310
- Acronym / sponsor ID
- FUSE / IRAS 321129
- Conditions
- Medical Emergencies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Betsi Cadwaladr University Health BoardOther government
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 10 Jan 2024 (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.
The investigators want to study how wearable devices can help track health changes in people when they are not feeling well. Normally, clinicians compare someone's vital signs, like heart rate, to average ranges from healthy folks. But what if clinicians compare these signs to the person's own normal when they were well? The investigators aim to check if wearable sensors can make this possible for many people. The investigators will look at heart rate differences when someone is admitted to the hospital compared to their stable days before. The investigators will see how their daily steps change a week before getting sick. This global study involves adults in emergency or acute care. Participation poses no risks, burdens, or immediate benefits to patients.
Detailed description
Rationale:
Abnormalities of vital signs are quantified by comparison with 'usual' ranges, which are those observed in resting healthy populations. It might be more appropriate to compare vital sign values of an individual that is in distress with their own usual values recorded when they were stable and well. Wearable sensors might make this possible at scale.
Objectives:
- To quantify the difference between heart rate on admission to acute care compared to the previously recorded vital signs when 24 hours and 1 week prior of the same patient.
- The change in daily steps taken by the patient in the week prior to admission to acute care
- To assess the feasibility of using heart rate data from patients' own wearable sensors.
Study design:
An asynchronous, international, multicentre observational study using the Flash Mob Research design.
Study population:
Patients aged 18 years and up who present at the Emergency Department, Acute Medical Department or Ambulatory Emergency Care with an acute complaint.
Main study parameters/endpoints:
- The difference between heart rate measured on presentation to acute care services, and measured prior when stable and well.
- The daily number of steps taken in the week prior to presentation to acute care services.
- The proportion of patients assessed for an acute complaint who have recordings of vital signs measured before they became unwell.
- A description of the population that uses devices that collect vital signs in terms of sex, age-group, digital literacy, and their severity of illness on presentation (as measured by a standard set of vital signs and frailty).
- The devices used to measure vital signs before they became unwell, and the vital signs they measure.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
There is no burden or risk associated with participation to patients, and no immediate benefit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients presenting to hospital with a medical condition / complaint.
Key inclusion criteria (5 listed)
- Have an acute presenting complaint
- Aged 18 years or older
- Uses any of the following: smart-watch, activity tracker, or other wearable monitoring device, a smart phone that collects data from other wearable device
- Ability to give informed consent
Key exclusion criteria (1 listed)
- Unable to give informed consent, including patients with immediately life-threatening 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
Hospital admission
Time frame: Within 24 hours of assessment
Proportion of patients admitted to hospital
2 secondary outcomes
Change in heart rate
Time frame: 1 week (+/- 1 day)
Change in step count
Time frame: 1 week (+/- 1 day)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
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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.
Christian Subbe principal investigator
YSBYTY Gwynedd 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 Medical Emergencies, run by Betsi Cadwaladr University Health Board 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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian P Subbe, DM (+447771922890, c.subbe@bangor.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital admission (time frame: Within 24 hours of assessment). 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 10 Jan 2024.