ANNE One-Wellue Device for Vital Sign Monitoring

(ANNE One TMRCT Trial)

Recruiting at 1 trial location

Overseen By Jane S Kim, MS MEd

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Non-English, Isolation, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 days

270 Participants Needed

Trial Summary

What is the purpose of this trial?

Randomized controlled trial of a time motion study of time spent obtaining and charting vital signs for inpatients, comparing use of a wireless Bluetooth vital sign array as intervention versus routine vital sign obtainment activity on a general medical floor.

Research Team

Gregory (Randy) R Smith Jr, MD MS

Principal Investigator

Northwestern University Feinberg School of Medicine

Eligibility Criteria

This trial is for healthcare staff on a general medical floor who regularly measure and chart patients' vital signs. It's designed to see if using a wireless Bluetooth device array changes the time they spend on these tasks.

Inclusion Criteria

Inpatients admitted to Northwestern Memorial Hospital, Feinberg Unit 16 West.

Exclusion Criteria

Under isolation status

Primary language other than English

Pregnant patients

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants are monitored for time spent obtaining and charting vital signs using either routine methods or the ANNE One device array

3 days

Daily monitoring

Follow-up

Participants' sleep quality and satisfaction are assessed post-discharge

4 weeks

Treatment Details

Interventions

• ANNE One-Wellue Device Array

Trial Overview The study is testing whether a new wireless Bluetooth vital sign array (ANNE One-Wellue) can make checking and recording patient vitals more efficient compared to the usual method. Staff are randomly chosen to use either the new device or continue with routine procedures.

Participant Groups

Group I: Intervention--Device Array Use Experimental Treatment 1 Intervention

Inpatients will wear the ANNE One device array for obtainment of vital sign assessments.

Group II: Control--Routine Vital Sign Obtainment Active Control 1 Intervention

Inpatients will have vital signs determined by routine practice, using any other standard of care-accepted method or device.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

University of Minnesota Medical School/University of Minnesota Foundation

Collaborator

Trials

1

Recruited

20+

Sibel Health Inc.

Industry Sponsor

Trials

5

Recruited

380+