Clinical trial NCT03646435: Use of Wearables in Hospitalized General Medicine Patients
Official title: Use of Fitbit Charge 2 in Hospitalized General Medicine Patients to Monitor Health Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hospitalizations
Keywords: inpatients
wearables
continuous monitoring
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: SCREENING

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.

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.

Eligibility 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.

Primary outcomes:
measure: Perceived usefulness of the wearable by patient
timeFrame: 6 days
measure: Perceived usefulness of the wearable by nurses/physicians
timeFrame: 6 days
Secondary outcomes:
measure: Correlation between Fitbit HR and HR obtained by nurses
timeFrame: 6 days
measure: Correlation between Fitbit sleep and sleep information gathered by patients
timeFrame: 6 days
measure: Correlation between Fitbit physical activity (number of steps taken) and activity information obtained by nurses
timeFrame: 6 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Robert Wu, MD
role: PRINCIPAL_INVESTIGATOR
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