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

Liver Cirrhosis, Alcoholic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06057870
• Other study ID #: STUDY00002606
• Status: Not yet recruiting
• Start date: April 10, 2024
• Est. completion date: July 30, 2025

Study information

• Verified date: February 2024
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with an admission diagnosis of decompensated cirrhosis based on Child-Turcotte-Pugh score of = 7 or MELD-Na score = 15, measured prior to discharge from the hospital. Cirrhosis of any etiology may be included. However, patients with cirrhosis due to autoimmune hepatitis must be on a stable corticosteroid dose for three months or more before study inclusion.

2.4.2 18 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.

2.4.5 Informed consent obtained from the subject and the ability of the subject to comply with the requirements of the study.

Exclusion Criteria:

• 2.5.1 Using a pacemaker, implantable cardiac defibrillator, neurostimulator, implantable hearing aids, cochlear implants, or other electronic medical equipment. However, removable hearing aids are permitted.

2.5.2 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.

2.5.6 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.

2.5.8 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."

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Liver Cirrhosis, Alcoholic

Intervention

Other:
• Application on Apple watch
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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