WATCH: Testing the Use of Home Monitoring Among Decompensated Cirrhosis Patients

Sponsor

University of California, San Francisco (Other)

Overall Status

Recruiting

CT.gov ID

NCT05928624

Collaborator

(none)

100

Enrollment

Location

Arms

24.5

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized single-blind feasibility trial to test the utilization of home blood pressure devices to improve the clinical management of decompensated cirrhosis patients.

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis, Liver Portal Hypertension Ascites Hepatic	Device: Withings Home Blood Pressure Device and Scale Other: Standard of Care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

Wireless Automated Tracking in Cirrhosis Patients at Home (WATCH) Trial: A Randomized Single Blind Trial Testing the Use of Home Monitoring Among Decompensated Cirrhosis Patients

Actual Study Start Date :

Jun 15, 2023

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Standard of Care This arm will receive a home blood pressure monitor and scale; however, these data will not be shared with their treating provider in real-time.	Other: Standard of Care Standard of Care
Experimental: Home Blood Pressure and Scale Monitoring to Inform Clinical Decisions This arm will receive a home blood pressure monitor and scale. These data will be reviewed weekly and these data will be shared with the treating provider to inform clinical decisions.	Device: Withings Home Blood Pressure Device and Scale The intervention will be whether the data generated from home monitoring devices are shared with the clinical providers. The investigators are not testing the efficacy of these approved devices.

Arm

Intervention/Treatment

Sham Comparator: Standard of Care

This arm will receive a home blood pressure monitor and scale; however, these data will not be shared with their treating provider in real-time.

Other: Standard of Care

Standard of Care

Experimental: Home Blood Pressure and Scale Monitoring to Inform Clinical Decisions

This arm will receive a home blood pressure monitor and scale. These data will be reviewed weekly and these data will be shared with the treating provider to inform clinical decisions.

Device: Withings Home Blood Pressure Device and Scale

The intervention will be whether the data generated from home monitoring devices are shared with the clinical providers. The investigators are not testing the efficacy of these approved devices.

Outcome Measures

Primary Outcome Measures

Change in Mean Arterial Pressure [Baseline and 24 Weeks]
The investigators will compare the change in mean arterial pressure before and after utilization of the data generated from the home monitoring.

Secondary Outcome Measures

Change in Ascites Burden [Baseline and 24 Weeks]
The investigators will compare the change in ascites burden, defined as the total volume of ascites removed during the study period, before and after utilization of the data generated from the home monitoring.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients will need to have decompensated cirrhosis defined as a Child Pugh Score ≥ 7

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California San Francisco	San Francisco	California	United States	94143

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator: Giuseppe Cullaro, MD, MAS, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT05928624

Other Study ID Numbers:

22-36046

First Posted:

Jul 3, 2023

Last Update Posted:

Jul 3, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 3, 2023