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Use of Wearables in Hospitalized General Medicine Patients

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ClinicalTrials.gov Identifier: NCT03646435
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Robert Wu, University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Hospitalizations Device: Fitbit Charge 2 Not Applicable

Detailed Description:

Patients admitted to general internal medicine are admitted because they are sick and need monitoring that cannot be provided at home, need expedited testing and/or need treatments that are best administered in hospital. Currently, standard monitoring on the hospital ward consists of measuring vital signs typically twice a day. The rapid development, uptake of affordable wearables such as smartwatches and wearable devices that involve continuous measurement of vital measures may provide added information to the care of inpatients. To date, there have been limited studies on the use of wearables in hospitalized medical patients. The rationale for the study is to determine feasibility of using wearables in GIM patients and usefulness of the data that wearables provide.

The wearable chosen for this study will be the Fitbit Charge 2. The Fitbit will be worn by all patients who are recruited to participate in the study. It will be worn like a watch on a wrist and uses photoplethysmography (PPG) to detect periodic changes in blood flow beneath the sensor; thereby measuring changes in heart rate. Heart rate will be measured nearly continuously. Fitbit will also assess activity and will also assess sleep. Fitbit data will be transmitted via Bluetooth to a mobile app which then is uploaded to Fitbit servers. The Fitbit data will then be accessed via the Web. The data will be downloaded from Fitbit servers to a secure UHN server.

In an effort to reduce the risk of potential iatrogenic infection, the study team will use disinfectant wipes to thoroughly clean wearables between uses. Participants will be shown how to wear the band by a study investigator or research personnel.

At the end of the study for each participant, the investigators will ask the questions related to how useful they found the data. For each participant, the study team will provide summary of their data to nurses and physicians who were caring for them. The investigators hope to get 2 nurse surveys per patient (because of there being multiple shifts per patient) and to get 1 attending survey per patient.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Screening
Official Title: Use of Fitbit Charge 2 in Hospitalized General Medicine Patients to Monitor Health Outcomes
Actual Study Start Date : June 12, 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : November 2019

Arm Intervention/treatment
Experimental: Wearable device (Fitbit Charge 2)
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
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).




Primary Outcome Measures :
  1. Perceived usefulness of the wearable by patient [ Time Frame: 6 days ]
    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.

  2. Perceived usefulness of the wearable by nurses/physicians [ Time Frame: 6 days ]
    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).


Secondary Outcome Measures :
  1. Correlation between Fitbit HR and HR obtained by nurses [ Time Frame: 6 days ]
    Upon termination of the study, the minute-level HR data gathered from Fitbit will be compared to the HR data collected by nurses in the GIM ward (every 6 hours) to see how consistent and accurate both methods are. Ultimately, averaged data collected from both methods will be presented graphically and the correlation coefficient (r2) between the two types of data will be reported.

  2. Correlation between Fitbit sleep and sleep information gathered by patients [ Time Frame: 6 days ]
    Upon termination of the study, an analysis will be done to assess if there is a correlation between the sleep data gathered by the Fitbit and the sleep information obtained by patients (via the Richards-Campbell Sleep Questionnaire). All patients enrolled in the study will be required to fill out the RCSQ after the study concludes. This RCSQ uses a visual analog scale (0-100) to assess 5 features of sleep: sleep depth, latency, awakenings, percentage of time awake, and overall quality of sleep. Ultimately, all the individual feature scores will be aggregated to develop a final RCSQ score for each patient. Higher scores indicate that patient has a good sleep pattern. The RCSQ scores of patients will then be compared to the sleep data gathered by the Fitbit and a correlation coefficient (r2) between the two types of data will be reported.

  3. Correlation between Fitbit physical activity (number of steps taken) and activity information obtained by nurses [ Time Frame: 6 days ]
    The physical activity data gathered by the Fitbit (ie. number of steps taken every day by the patient) will be compared to the nurses' daily assessment of the patients which includes a Braden scale (for predicting pressure sore risk). The braden score consists of 6 categories: sensory perception, moisture, activity, mobility, nutrition and friction. The score ranges from 6-23 with lower scores indicating a higher risk. The Braden scores gathered by nurses for every patient in the study will be compared to each patient's Fitbit data to assess for accuracy and consistency. Ultimately, averaged data collected from both methods will be presented graphically and a correlation coefficient (r2) between the two types of data will be reported.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646435


Contacts
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Contact: Robert Wu, MD 416 340 4567 robert.wu@uhn.ca
Contact: Vikas Patel, BMSc 519 702 2570 vik.patel@mail.utoronto.ca

Locations
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Canada, Ontario
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Robert Wu, MD    416 340 4567    robert.wu@uhn.ca   
Contact: Vikas Patel, BMSc    519 702 2570    vik.patel@mail.utoronto.ca   
Principal Investigator: Robert Wu, MD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Robert Wu, MD University Health Network, Toronto

Publications:

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Responsible Party: Robert Wu, GIM Site Director, TGH, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03646435     History of Changes
Other Study ID Numbers: 18-5621
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Robert Wu, University Health Network, Toronto:
inpatients
wearables
continuous monitoring