Use of Wearables in Hospitalized General Medicine Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-12

Study Completion Date

2019-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Validation of Fitbit Measurements in Hospitalized General Medicine Patients

NCT07229833

GIM Diagnosis Medicine Admission to GIM

ACTIVE_NOT_RECRUITING

Using Fitbit to Monitor Ambulation in Patients After Surgery.

NCT02741895

General Surgery

COMPLETED

Early Detection of Infection Using the Fitbit in Pediatric Surgical Patients

NCT06395636

Appendectomy Appendicitis Appendicitis Acute

RECRUITING NA

Use of Wearables Following Cystectomy- Part II

NCT07148765

Bladder Cancer Neurogenic Bladder Disorder Cystectomy

ENROLLING_BY_INVITATION NA

Wearable Technology for Hospital Inpatients

NCT02527408

Heart Rate Monitoring

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hospitalizations

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

SCREENING

Blinding Strategy

NONE

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Fitbit Charge 2

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No