Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06199310 |
| Other study ID # |
IRAS 321129 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 30, 2023 |
| Est. completion date |
December 1, 2024 |
Study information
| Verified date |
December 2023 |
| Source |
Betsi Cadwaladr University Health Board |
| Contact |
Christian P Subbe, DM |
| Phone |
+447771922890 |
| Email |
c.subbe[@]bangor.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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. 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.
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.
