Use of Wearables in Hospitalized General Medicine Patients

NCT03646435 | Completed

• 1 other identifier: 18-5621
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study will focus to determine the usefulness of continuous monitoring and the role it would play in improving inpatient management. The study is also conducted to collect patient's experiences regarding use of the wearable device for health monitoring. There will be no control or comparison group for this prospective cohort study. For each participant, the investigators will provide summary of their data to nurses and physicians who are directly involved in the patients' care. At the end of the study for each participant, the investigators will ask questions related to how useful they found the data. As a secondary endpoint for this study, the study team will also be evaluating the accuracy of the heart rate, sleep and activity data gathered from the wearable against the current gold standard used in hospitals (ie. information gathered by nurses or using sleep assessment patient questionnaires). The investigators predict that wearable devices will be well received among participants and that they can provide accurate information about patients on GIM.

Conditions

Hospitalizations

Keywords

inpatients; wearables; continuous monitoring

Outcome Measures

Primary Outcomes (2)

• Perceived usefulness of the wearable by patient

  Patients will be given a 'patient questionnaire' that is developed by the research team to provide feedback about their experience and how useful/feasible (if at all) they found the wearable to be in collecting their health information. The questionnaire is not adopted from any other source or the literature. There will be a mix of 10 questions (open-ended short answer or scale-based from 1-10) on the questionnaire. Higher scores will indicate that patients felt that their Fitbit data correlated well with their behaviour and nurses' vital sign assessment.

  6 days

• Perceived usefulness of the wearable by nurses/physicians

  Nurses and physicians will be given a 'clinician questionnaire' which is also developed by the research team, to report how clinically useful they felt the Fitbit data was. There will be a mix of 6 questions (open-ended short answer or scale-based from 1-10) on the questionnaire. Higher scores on questionnaire indicate that nurses and physicians felt that the Fitbit data was mostly consistent with the nurses' assessment (which was conducted every 6 hours).

  6 days

Secondary Outcomes (3)

• Correlation between Fitbit HR and HR obtained by nurses

  6 days

• Correlation between Fitbit sleep and sleep information gathered by patients

  6 days

• Correlation between Fitbit physical activity (number of steps taken) and activity information obtained by nurses

  6 days

Study Arms (1)

Wearable device (Fitbit Charge 2)

EXPERIMENTAL

The Fitbit Charge 2 is the wearable of interest for this pilot study. All 50 study participants will be requested to wear the electronic device for the duration of their stay in the hospital (maximum of 6 days). The Fitbit will passively collect health information of patients which will be tracked on mobile devices by the study investigators.

Device: Fitbit Charge 2

Interventions

Fitbit Charge 2 DEVICE

The Fitbit Charge 2 is the electronic wearable chosen for this pilot study. This particular Fitbit is capable of measuring patient heart rate, sleep and physical activity. The data collected will then be analyzed with respect to the outcomes of this study. To determine the accuracy of the Fitbit, data collected will be compared to the nurses' standard patient assessment (for HR and physical activity) and to patient responses on the Richards-Campbell Sleep Questionnaire (for sleep).

Wearable device (Fitbit Charge 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• General internal medicine patients admitted to General Medicine Wards.
• Able to consent.
• Able to speak English.
• years of age or older

You may not qualify if:

• Patients who are purely palliative "comfort measures only" where measuring vital signs would not be appropriate and will be excluded.
• To reduce the potential risk of transmitting nosocomial infections, patients under contact precautions for methicillin resistant Staphylococcus aureus (MRSA) and Clostridium difficile infections will also be excluded.
• We will also excluded patients at risk of vascular compromise of the arm on which the wearable device was to be placed, such as patients with upper extremity deep venous thrombosis, peripherally inserted central catheters, radial arterial lines, dialysis fistulas, and severe upper extremity trauma.
• We will exclude patients with significant cognitive impairment as patients will be required to complete daily surveys.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (8)

• Helton MC, Gordon SH, Nunnery SL. The correlation between sleep deprivation and the intensive care unit syndrome. Heart Lung. 1980 May-Jun;9(3):464-8. No abstract available.

  PMID: 6901518 BACKGROUND

• Pires GN, Bezerra AG, Tufik S, Andersen ML. Effects of acute sleep deprivation on state anxiety levels: a systematic review and meta-analysis. Sleep Med. 2016 Aug;24:109-118. doi: 10.1016/j.sleep.2016.07.019. Epub 2016 Aug 27.

  PMID: 27810176 BACKGROUND

• Roehrs T, Hyde M, Blaisdell B, Greenwald M, Roth T. Sleep loss and REM sleep loss are hyperalgesic. Sleep. 2006 Feb;29(2):145-51. doi: 10.1093/sleep/29.2.145.

  PMID: 16494081 BACKGROUND

• Baldwin C, van Kessel G, Phillips A, Johnston K. Accelerometry Shows Inpatients With Acute Medical or Surgical Conditions Spend Little Time Upright and Are Highly Sedentary: Systematic Review. Phys Ther. 2017 Nov 1;97(11):1044-1065. doi: 10.1093/ptj/pzx076.

  PMID: 29077906 BACKGROUND

• Abeles A, Kwasnicki RM, Pettengell C, Murphy J, Darzi A. The relationship between physical activity and post-operative length of hospital stay: A systematic review. Int J Surg. 2017 Aug;44:295-302. doi: 10.1016/j.ijsu.2017.06.085. Epub 2017 Jul 6.

  PMID: 28689861 BACKGROUND

• 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.

  PMID: 27651304 BACKGROUND

• 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.

  PMID: 29201377 BACKGROUND

• Appelboom G, Camacho E, Abraham ME, Bruce SS, Dumont EL, Zacharia BE, D'Amico R, Slomian J, Reginster JY, Bruyere O, Connolly ES Jr. Smart wearable body sensors for patient self-assessment and monitoring. Arch Public Health. 2014 Aug 22;72(1):28. doi: 10.1186/2049-3258-72-28. eCollection 2014.

  PMID: 25232478 BACKGROUND

Study Officials

• Robert Wu, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: After all the study participants are recruited, they will be assigned a study ID which investigators will use to anonymize data and track patient health data that is collected via the Fitbit.
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: GIM Site Director, TGH

Model Details: This study model will involve a single cohort of about 50 GIM patients. All patients will be asked to wear the Fitbit Charge 2 for the duration of their stay in the hospital and the health information (heart rate, sleep, physical activity) collected from the wearable will be compared to the nurses' vital sign assessment for accuracy. There will be no other comparison group in this study.

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: August 24, 2018
• Study Start: June 12, 2019
• Primary Completion: October 5, 2019
• Study Completion: November 1, 2019
• Last Updated: December 3, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)