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

NCT ID: NCT06995742

Last Updated: 2025-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-02

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention--Device Array Use

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

Group Type EXPERIMENTAL

Device Array Use

Intervention Type 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.

Control--Routine Vital Sign Obtainment

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

Group Type ACTIVE_COMPARATOR

Routine Vital Sign Measurement

Intervention Type 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.

Interventions

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Device Array Use

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 Type DEVICE

Routine Vital Sign Measurement

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota Medical School/University of Minnesota Foundation

UNKNOWN

Sponsor Role collaborator

Sibel Health Inc.

INDUSTRY

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Gregory Randall Smith Jr

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gregory (Randy) R Smith Jr, MD MS

Role: PRINCIPAL_INVESTIGATOR

Northwestern University Feinberg School of Medicine

Locations

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Feinberg 16 West, Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status RECRUITING

Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Gregory (Randy) R Smith Jr, MD MS

Role: CONTACT

312-926-5893

Jane S Kim, MS MEd

Role: CONTACT

312-926-7272

Facility Contacts

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Gregory R Smith Jr, MD MS

Role: primary

312-926-5893

Gregory (Randy) R Smith Jr, MD MS

Role: primary

312-926-5893

Other Identifiers

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2023 Dixon Translational Grant

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STU00219340

Identifier Type: -

Identifier Source: org_study_id

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