Feasibility of Wearable Biosensors for Monitoring Daily Activity, Heart Rate, and Sleep Among Patients With Decompensated Cirrhosis

NCT06057870 | Not Yet Recruiting

• 1 other identifier: STUDY00002606
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this protocol, the investigators will determine compliance, acceptability, and patient satisfaction regarding the use of remote monitors and summarize changes in activity over time among patients with decompensated cirrhosis. This is a feasibility pilot study that will recruit 20 patients. The investigators plan to determine the feasibility of wearable devices to remotely monitor daily activity (e.g., physical activity, sedentary time, sleep), cognitive function, blood pressure, and weight in patients with decompensated cirrhosis, by assessing patient compliance. A patient is considered compliant if they wear the wristwatch at least 10 hours per day and use the Apps, body weight scale, and blood pressure monitor for at least 4 of 7 days

Conditions

Liver Cirrhosis, Alcoholic

Outcome Measures

Primary Outcomes (1)

• Feasibility and acceptability of using remote health monitoring

  To determine the feasibility and engagement with remote management of acutely decompensated cirrhosis patients using CirrhoCare® App, CyberLiver ART App, and remote monitors by assessing patient adherence to the monitoring device and the Apps over a 3-month period. After the 3-month study period, the participants can opt to remain in contact using the App. If they agree, they will be contacted at 6 months and a year.

  up to 1 year

Interventions

Application on Apple watch OTHER

To determine the feasibility and engagement with remote management of acutely decompensated cirrhosis patients using CirrhoCare® App, CyberLiver ART App, and remote monitors by assessing patient adherence to the monitoring device and the Apps over a 3-month period.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with decompensated cirrhosis who are admitted to the hospital will be screened for eligibility and approached before discharge. If they are eligible for the study and if so, the potential subject is presented with an option of enrolling.

You may qualify if:

• years or older 2.4.3 Ambulatory (use of walking aids, such as cane and rollator, is acceptable) 2.4.4 Have an understanding, ability, and willingness to fully comply with study procedures and restrictions as determined by the principal investigator.
• Informed consent obtained from the subject and the ability of the subject to comply with the requirements of the study.

You may not qualify if:

• Using a pacemaker, implantable cardiac defibrillator, neurostimulator, implantable hearing aids, cochlear implants, or other electronic medical equipment. However, removable hearing aids are permitted.
• Presence of advanced or terminal stage hepatocellular carcinoma 2.5.3 Patients with current extrahepatic malignancies including solid tumors and hematologic disorders 2.5.4 Patients with an ongoing ACLF (see diagnostic criteria in reference16) 2.5.5 Patients with a history of significant extrahepatic disease with impaired short-term prognosis, including congestive heart failure New York Heart Association Grade III/IV, COPD GOLD \>2, chronic kidney disease defined by KDIGO criteria, or under renal replacement therapy.
• Presence of any extra-hepatic malignancy not in remission for \> 12 months 2.5.7 Pregnancy, since being pregnant may alter heart rate and sleep patterns. Women of childbearing age remain eligible.
• Inability or refusal to provide informed consent by the patient 2.5.9 Patients with hepatic encephalopathy New Haven grade 1 or greater. 2.5.10 Any records flagged "break the glass" or "research opt out."

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

MeSH Terms

Conditions

Liver Cirrhosis, Alcoholic

Condition Hierarchy (Ancestors)

Liver Cirrhosis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: September 28, 2023
• Study Start: April 10, 2024
• Primary Completion: December 30, 2024
• Study Completion: July 30, 2025
• Last Updated: February 8, 2024

Record last verified: 2024-02