Actively Recruiting
Effect of ANNE One-Wellue Device Array Use on Staff Bedside Vital Sign Measurement Activity: A Randomized Controlled Trial
Led by Northwestern University · Updated on 2025-06-05
270
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
U
University of Minnesota Medical School/University of Minnesota Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial examines how a wireless Bluetooth vital sign array device called the ANNE One-Wellue affects the time hospital staff spend obtaining and recording vital signs for inpatients. It is a randomized controlled trial comparing this new device method to the routine vital sign measurement practices on a general medical floor. The study also looks at patient sleep quality, satisfaction, and healthcare provider experience. Participants in the intervention group will wear the ANNE One device array, which includes sensors worn on the chest, finger, and arm, plus an oral temperature probe used by staff. The control group will have vital signs measured using standard methods without the device array. The study collects data on time spent obtaining and documenting vital signs each day for up to three days per patient. During the study, researchers will assess the total time spent on vital sign measurement by staff, survey patients about their sleep quality during the hospital stay and after discharge, and gather feedback from healthcare providers about using the device array. Surveys are conducted at specified intervals, and all participants will be monitored throughout their hospital stay. The study is sponsored by Northwestern University and is expected to complete by July 2026.
CONDITIONS
Brief Title
Effect of ANNE One-Wellue Device Array Use on Staff Bedside Vital Sign Measurement Activity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Inpatients admitted to Northwestern Memorial Hospital, Feinberg Unit 16 West
- Age 18 years or older
- Able to communicate in English
You will not qualify if you...
- Primary language other than English
- Under isolation status
- Pregnant patients
- Prisoners
- Employees or students of the hospital or Northwestern University
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 days during hospital stay
Participants will either wear the ANNE One wireless vital sign device array or have their vital signs obtained by routine care methods while hospitalized.
Daily vital sign assessments for up to 3 days
Duration - Up to 30 days after hospital discharge
Participants complete surveys to assess sleep quality and satisfaction, and healthcare providers complete experience surveys with the device.
1 survey 24-72 hours after enrollment, 1 survey within a week of discharge, and 2 provider surveys during the study
Trial Site Locations
Total: 2 locations
1
Feinberg 16 West, Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
2
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Not Yet Recruiting
Research Team
G
Gregory (Randy) R Smith Jr, MD MS
J
Jane S Kim, MS MEd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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