Wearable Technology for Hospital Inpatients (WEARIT-IN)

April 4, 2016 updated by: Dr. David Maslove, Queen's University
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.

Study Overview

Status

Completed

Conditions

Detailed Description

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:

  1. 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.
  2. To determine the accuracy and completeness of high-frequency heart rate measurements recorded from personal fitness trackers in hospital inpatients.
  3. To compare measurements of sleep quality generated by personal fitness trackers with clinical assessments by nursing staff among hospital inpatients.
  4. To develop a workflow and data analysis pipeline for downloading, storing, analyzing, and visualizing data generated by personal fitness trackers worn by hospital inpatients.
  5. 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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult intensive care unit patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate accuracy
Time Frame: 6 months
Percentage of heart rate measurements that are within 5 beats per minute of telemetry reading
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Agreement with sleep quality questionnaire
Time Frame: 6 months
Correlation between Fitbit derived sleep quality score, and the Richards-Campbell Sleep Questionnaire
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University

Investigators

  • Principal Investigator: David Maslove, Queen's University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

August 13, 2015

First Submitted That Met QC Criteria

August 17, 2015

First Posted (Estimate)

August 19, 2015

Study Record Updates

Last Update Posted (Estimate)

April 5, 2016

Last Update Submitted That Met QC Criteria

April 4, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • DMED-1818-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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