Wearable Technology for Hospital Inpatients | NCT02527408

Studies
Wearable Technology for Hospital Inpatients

NCT02527408

Sponsor

Queen's University

Status

Completed

Last Update Posted

Apr 5, 2016Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Heart Rate Monitoring

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

Feb 2016Actual

Completion Date

Feb 2016Actual

First Submitted Date

Aug 13, 2015

First Submission Date that Met QC Criteria

Aug 17, 2015

First Posted Date

Aug 19, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2016

Last Update Posted Date

Apr 5, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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:

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult intensive care unit patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Maslove	Queen's University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kingston General Hospital		Kingston	Ontario	K7L 2V7	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29201377	Derived	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.
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