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NCT Number: NCT06995742

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Feinberg 16 West, Northwestern Memorial Hospital, Chicago, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Time Motion Assessment of Time Spent Obtaining and Recording Vital Signs

    Time frame: 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.

    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 outcomes

  1. Sleep Quality of Inpatient Study Participants

    Time frame: Survey 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.

  2. Patient Satisfaction with Inpatient Sleep Quality

    Time frame: Survey 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.

  3. Healthcare Provider Experience with the Vital Sign Device Array

    Time frame: The 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gregory (Randy) R Smith Jr, MD MS

CONTACT

[email protected]

312-926-5893

Jane S Kim, MS MEd

CONTACT

[email protected]

312-926-7272

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Sibel Health Inc.
  • University of Minnesota

Registry information

Official study title

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

Acronym: ANNE One TMRCT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 29, 2025
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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