Feasibility of Using resting heart rate and step-counts from patient-held Sensors during clinical assessment of medical Emergencies (FUSE): Protocol for a prospective observational study in European hospitals (Preprint)

Background:

Abnormalities of vital signs are quantified by comparison with ‘normal’ ranges, which are those observed in resting healthy populations. It might be more appropriate to compare the vital sign values of an individual in distress with their own usual values recorded when they were stable and well. Wearable sensors might make this possible at scale.

Objective:

• To assess the feasibility of using heart rate and mobility data from patients’ own wearable sensors as part of clinical assessments at time of presentation to hospital with medical emergencies. • To quantify the difference between heart rate on admission to acute care compared to the previously recorded heart rate 24 hours and 1 week prior of the same patient. • To quantify the change in daily steps taken by the patient in the week prior to admission to acute care.

Methods:

Study design: An international, multicentre observational study using the Flashmob 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 medical 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.

Results:

The study has been registered on ClinicalTrials.gov and passed the required approvals in the Netherlands. (MEC-2022-0795). And the United Kingdom (IRAS 321129). Recruitment has started in the first site in the United Kingdom to test study procedures. The Flashmob part of the study will be undertaken in 40 participating hospitals throughout Europe in May 2024.

Conclusions:

With the increasing availability of consumer held devices able to record medically relevant information this study will provide information about the availability of this data in a number of European settings. Clinical Trial: ClinicalTrials.gov submitted.