Pfizer COVID-19 vaccine appointments are available to our patients. Sign up for Connect today to schedule your vaccination.

A Pragmatic Observational Study of Biometrics Collected by Wearable Technology in Patients with Liver Disease

Clinical Trial Details

This is a prospective pilot study evaluating the ability of an Oura fitness tracker to evaluate the various physiologic changes that happen in chronic liver disease (cirrhosis).

The purpose of this study is to see if the Oura fitness tracker may be able to detect subtle changes that correlate to how patients are feeling, complications they may have, or relationships with outcomes. Commercial wearables (examples include Apple Watch and FitBit) are very interesting in the medical community, as they may help better identify and manage disease states. However, most research has been conducted in healthy volunteers, and it’s unclear if the problems seen in cirrhosis can be detected accurately with wearables.

The Oura fitness tracker is a wearable ring which functions similarly to other wearables by passively collecting data on heart rate, activity levels, sleep stages, and recovery. It is commercially available and is not considered a medical device by the U.S. Food and Drug Administration (FDA); as such, it is not at this time evaluated or approved for the diagnosis or treatment of any disease, including liver disease.
   
If an individual agrees to participate and meets all the requirements, they will be provided an Oura tracker for a period of 6 months, during which time they will continue to receive standard-of-care management by their liver doctor including any office visits, laboratory tests, and imaging. No additional medications, blood draws, or imaging is needed, but patients will have 2 blood draws that are to be performed as part of their standard care and at a standard office visit.
   
Additional participation includes an approximately 30-minute survey three times over the course of the study, as well as brief check in phone calls to ensure that the tracker is functioning properly. These surveys will be conducted by an independent researcher at the time of standard office visit. Participants may use the Oura tracker for their own personal use during the duration of the study but must be returned at the conclusion of the study. There is no additional compensation for participation in this study.

Key Eligibility: 
  1. Men and women who are 18 years of age and older.
  2. Have been diagnosed with cirrhosis.
  3. Have not been recently hospitalized for an episode of hepatic encephalopathy.

Detailed eligibility reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Mallory Ianelli, RN, BSN
(646) 962-4040
mai2016@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2207025079

Sponsor:

C928-020

Status

Open to Enrollment

Age Group

Adult

Sponsor