Wearable Technology for Hospital Inpatients

Completed

• Conditions: Heart Rate Monitoring

• Registration Number: NCT02527408
• Lead Sponsor: Queen's University

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:

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 Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-13
• Study First Submitted QC: 2015-08-17
• Study First Posted: 2015-08-19
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-04
• Last Update Posted: 2016-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Heart rate accuracy	6 months	Percentage of heart rate measurements that are within 5 beats per minute of telemetry reading

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada