Clinical trial NCT02527408: Wearable Technology for Hospital Inpatients
Official title: Wearable Technology for Hospital Inpatients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Rate Monitoring
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult intensive care unit patients

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Heart rate accuracy
timeFrame: 6 months
Secondary outcomes:
measure: Agreement with sleep quality questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
Study officials:
affiliation: Queen's University
name: David Maslove
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.