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OpenTrials
Completed

NCT Number: NCT02527408

Wearable Technology for Hospital Inpatients

This study will address the feasibility of using wrist-worn fitness trackers to monitor hospital inpatients. The study is being conducted in the Intensive Care Unit where patients are closely monitored, in order to provide gold standard measurements of heart rate, and accurate estimates of sleep quality.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

About this study

Overall Hypothesis:

The use of wearable personal fitness trackers to monitor physiologic signals in hospital inpatients is feasible, reliable, secure, and cost effective.

Specific Objectives:

  • To evaluate the feasibility of applying a wrist-worn personal fitness tracker to hospital inpatients for the purpose of monitoring heart rate and sleep quality during the night.
  • To determine the accuracy and completeness of high-frequency heart rate measurements recorded from personal fitness trackers in hospital inpatients.
  • To compare measurements of sleep quality generated by personal fitness trackers with clinical assessments by nursing staff among hospital inpatients.
  • To develop a workflow and data analysis pipeline for downloading, storing, analyzing, and visualizing data generated by personal fitness trackers worn by hospital inpatients.
  • To evaluate the feasibility of a larger prospective multicenter trial examining the utility of personal fitness trackers among hospital inpatients, including recruitment rates, inclusion/exclusion criteria, data management protocols, and outcomes measures.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients (age > 18 years)
  • Spontaneously breathing (i.e. no invasive or non-invasive mechanical ventilation, with the exception of nocturnal non-invasive ventilation at stable home settings)
  • Cardiac telemetry and/or continuous SpO2 monitoring in place

Exclusion criteria

  • Continuous sedation or analgesia
  • Known upper extremity deep venous thrombosis
  • Dialysis fistula
  • Radial arterial line in the non-dominant arm
  • Peripherally inserted central venous catheter in the non-dominant arm
  • Severe upper extremity trauma or fracture
  • History of upper extremity amputation
  • Skin breakdown at application site
  • Contact precautions (methicillin resistant Staph aureus, C. difficile, vancomycin resistant Enterococcus)

Treatment and study plan

Primary outcomes

  1. Heart rate accuracy

    Time frame: 6 months

    Percentage of heart rate measurements that are within 5 beats per minute of telemetry reading

Secondary outcomes

  1. Agreement with sleep quality questionnaire

    Time frame: 6 months

    Correlation between Fitbit derived sleep quality score, and the Richards-Campbell Sleep Questionnaire

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Registry information

Acronym: WEARIT-IN

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 19, 2015
Registry last updated
Apr 5, 2016

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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