FUSE - Feasibility of Patient Held Sensors for Medical Emergencies

NCT06199310 | Unknown

• 1 other identifier: IRAS 321129
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Medical Emergencies

Outcome Measures

Primary Outcomes (1)

• Hospital admission

  Proportion of patients admitted to hospital

  Within 24 hours of assessment

Secondary Outcomes (2)

• Change in heart rate

  1 week (+/- 1 day)

• Change in step count

  1 week (+/- 1 day)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to hospital with a medical condition / complaint.

You may qualify if:

• 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

You may not qualify if:

• Unable to give informed consent, including patients with immediately life-threatening illness

Sponsors & Collaborators

• Betsi Cadwaladr University Health Board: lead

Study Sites (1)

Ysbyty Gwynedd

Bangor, LL57 2PW, United Kingdom

RECRUITING

Study Officials

• Christian Subbe

  YSBYTY Gwynedd Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian P Subbe, DM

CONTACT

+447771922890; c.subbe@bangor.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Physician, Senior Clinical Lecturer

Study Record Dates

• First Submitted: December 3, 2023
• First Posted: January 10, 2024
• Study Start: June 30, 2023
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 10, 2024

Record last verified: 2023-12

Locations

GB (1)