Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06199310
Status:
RECRUITING
Last Update Posted:
2024-01-10
First Post:
2023-12-03
Brief Title:
FUSE - Feasibility of Patient Held Sensors for Medical Emergencies
Sponsor:
Betsi Cadwaladr University Health Board
Organization:
Betsi Cadwaladr University Health Board
Study Overview
Official Title:
Feasibility of Using Resting Heart Rate and Step-counts From Patient-held Sensors During Clinical Assessment of Medical Emergencies FUSE
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FUSE
Brief 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 someones vital signs like heart rate to average ranges from healthy folks But what if clinicians compare these signs to the persons 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 parametersendpoints
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
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 parametersendpoints
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None