NCT02527408

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

April 5, 2016

Status Verified

April 1, 2016

Enrollment Period

6 months

First QC Date

August 13, 2015

Last Update Submit

April 4, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Heart rate accuracy

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

    6 months

Secondary Outcomes (1)

  • Agreement with sleep quality questionnaire

    6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult intensive care unit patients

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Related Publications (2)

  • Kroll RR, McKenzie ED, Boyd JG, Sheth P, Howes D, Wood M, Maslove DM; WEARable Information Technology for hospital INpatients (WEARIT-IN) study group. Use of wearable devices for post-discharge monitoring of ICU patients: a feasibility study. J Intensive Care. 2017 Nov 21;5:64. doi: 10.1186/s40560-017-0261-9. eCollection 2017.

  • Kroll RR, Boyd JG, Maslove DM. Accuracy of a Wrist-Worn Wearable Device for Monitoring Heart Rates in Hospital Inpatients: A Prospective Observational Study. J Med Internet Res. 2016 Sep 20;18(9):e253. doi: 10.2196/jmir.6025.

Study Officials

  • David Maslove

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 13, 2015

First Posted

August 19, 2015

Study Start

August 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

April 5, 2016

Record last verified: 2016-04

Locations