Effect of ANNE One-Wellue Device Array Use on Staff Bedside Vital Sign Measurement Activity

NCT06995742 | Recruiting FDA Device

• 2 other identifiers: STU002193402023 Dixon Translational Grant
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Vital Sign Evaluation; Vital Sign Monitoring; Sleep Quality; Provider Behavior; Patient Satisfaction

Keywords

time motion study; vital signs; sleep quality; inpatient sleep; wireless device; patient satisfaction

Outcome Measures

Primary Outcomes (1)

• Time Motion Assessment of Time Spent Obtaining and Recording Vital Signs

  The number of seconds spent by a healthcare provider obtaining and charting vital signs will be witnessed and recorded by a research staff member.

  Number of seconds spent obtaining and charting vital signs is obtained at 8a daily, for maximum of three days for each study participant, and are added together to equal the total time spent on vital sign assessment.

Secondary Outcomes (3)

• Sleep Quality of Inpatient Study Participants

  Survey conducted 24-72 hours after enrolment.

• Patient Satisfaction with Inpatient Sleep Quality

  Survey sent within a week of hospital discharge and collected within the subsequent thirty days.

• Healthcare Provider Experience with the Vital Sign Device Array

  The electronic survey will be administered twice during the study. Each survey will take approximately ten minutes to complete.

Study Arms (2)

Intervention--Device Array Use

EXPERIMENTAL

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

Device: Device Array Use

Control--Routine Vital Sign Obtainment

ACTIVE COMPARATOR

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

Device: Routine Vital Sign Measurement

Interventions

Device Array Use DEVICE

Study participants assigned to the intervention study arm will wear a wireless Bluetooth capable vital sign detection array, with one device externally worn on each of their chest, one finger, and one arm, with healthcare providers using an additional oral temperature probe.

Intervention--Device Array Use

Routine Vital Sign Measurement DEVICE

Study participants randomized to the control arm will have their vital signs obtained by routine means, without use of the wireless vital sign device array.

Control--Routine Vital Sign Obtainment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Primary language other than English, under isolation status, pregnant patients, prisoners, employees or students of the hospital or Northwestern University.

Sponsors & Collaborators

• Northwestern University: lead
• University of Minnesota Medical School/University of Minnesota Foundation: collaborator
• Sibel Health Inc.: collaborator

Study Sites (2)

Feinberg 16 West, Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

RECRUITING

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Patient Satisfaction

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Gregory (Randy) R Smith Jr, MD MS

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory (Randy) R Smith Jr, MD MS

CONTACT

312-926-5893; g.smith@nm.org

Jane S Kim, MS MEd

CONTACT

312-926-7272; jane.kim@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 29, 2025
• Study Start: June 2, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)