The Role of Wearable Devices in Predicting and Detecting Complications and Adverse Events

Mass General Brigham

Status: Enrolling

Conditions: Treatment Complication; Recovery

Treatments: Device: Device: Wearable Device

Study type: Observational

Funder types: Other

Identifiers

NCT04824066

2020P002984

Details and patient eligibility

About

The overarching goal of this research is to use machine learning analysis of high-resolution data-collected by wearable technology-to predict complications and poor recovery in patients undergoing treatment for benign or malignant conditions.

Full description

This is a multi-center non-randomized prospective cohort study using wearable devices and machine learning to predict complications and poor recovery in patients undergoing treatment for benign or malignant conditions.

Patients who meet the inclusion and exclusion criteria will be enrolled consecutively with verbal informed consent from the time this protocol is approved by the IRB until 2,400 subjects are enrolled. At ~30 days before treatment the subjects will have a wearable device (such as a Fitbit) placed on their wrist and will wear the device for up to 5 years following treatment. This device will wirelessly transmit data regarding activity and sleep quality to a smartphone application for the duration of wear and data will be analyzed by our collaborators at Case Western Reserve University.

Enrollment: 2,400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 years or older
2. Individuals scheduled to undergo one of the following surgical or non-surgical treatments: cardiothoracic surgery, orthopedic surgery, vascular surgery, colorectal surgery, pancreatic surgery, other major abdominal surgeries, treatment for chronic disease, or systemic therapy (i.e., chemotherapy, immunotherapy, or targeted therapy), radiotherapy, or ablation.
3. Amenable to using one of the wearable devices of interest (Fitbit, iWatch, Biostrap).
4. Individuals willing to provide informed consent and who have capacity for all study procedures

Exclusion criteria

1. Individuals with mental incapacity and/or cognitive impairment that would preclude adequate understanding of, or cooperation with the study protocol.
2. Any pregnant participant.

Trial design

2,400 participants in 1 patient group

Treatment Group

Description:

Adults patients who are scheduled to undergo treatment for a benign or malignant condition and meet the inclusion and exclusion criteria.

Treatment:

Device: Device: Wearable Device