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

Effect of ANNE One-Wellue Device Array Use on Staff Bedside Vital Sign Measurement Activity: A Randomized Controlled Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06995742
Acronym
ANNE One TMRCT
Enrollment
270
Registered
2025-05-29
Start date
2025-06-02
Completion date
2026-07-31
Last updated
2025-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

DEVICEDevice 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.

DEVICERoutine 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.

Sponsors

University of Minnesota Medical School/University of Minnesota Foundation
CollaboratorUNKNOWN
Sibel Health Inc.
CollaboratorINDUSTRY
Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Randomized Controlled Trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Time Motion Assessment of Time Spent Obtaining and Recording Vital SignsNumber 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.The number of seconds spent by a healthcare provider obtaining and charting vital signs will be witnessed and recorded by a research staff member.

Secondary

MeasureTime frameDescription
Sleep Quality of Inpatient Study ParticipantsSurvey conducted 24-72 hours after enrolment.Sleep quality will be determined by use of the Potential Hospital Sleep Disruptions and Noises Questionnaire survey, administered to study participants after a night of study enrolment. The survey scores sleep quality from 1 to 5 with 1 signifying no disruption and 5 signifying extreme disruption.
Patient Satisfaction with Inpatient Sleep QualitySurvey sent within a week of hospital discharge and collected within the subsequent thirty days.Question 8, During this hospital stay, how often were you able to get the rest you needed? of the Hospital Consumer Assessment of Healthcare Providers and Systems post-discharge questionnaire will be collected for study participants. Survey responses include: never, sometimes, usually, always.
Healthcare Provider Experience with the Vital Sign Device ArrayThe electronic survey will be administered twice during the study. Each survey will take approximately ten minutes to complete.Healthcare providers who use the device array will be surveyed with a Technology Acceptance Method survey to assess usability of the device array.

Countries

United States

Contacts

Primary ContactGregory (Randy) R Smith Jr, MD MS
g.smith@nm.org312-926-5893
Backup ContactJane S Kim, MS MEd
jane.kim@northwestern.edu312-926-7272

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026