Wearable Technology for Hospital Inpatients

Heart Rate Monitoring Clinical Trial

— WEARIT-IN  

Official title:

Wearable Technology for Hospital Inpatients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02527408
• Other study ID #: DMED-1818-15
• Status: Completed
• Phase: N/A
• First received: August 13, 2015
• Last updated: April 4, 2016
• Start date: August 2015
• Est. completion date: February 2016

Study information

• Verified date: April 2016
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Rate Monitoring

Locations

Country	Name	City	State
Canada	Kingston General Hospital	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate accuracy	Percentage of heart rate measurements that are within 5 beats per minute of telemetry reading	6 months	Yes
Secondary	Agreement with sleep quality questionnaire	Correlation between Fitbit derived sleep quality score, and the Richards-Campbell Sleep Questionnaire	6 months	No