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A Pilot Trial to Test the Feasibility of Utilizing Home Blood Pressure Monitoring to Optimize the Administration of Midodrine Among Decompensated Cirrhosis Patients (WATCH)

Primary Purpose

Cirrhosis, Liver, Portal Hypertension, Ascites Hepatic

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Withings Home Blood Pressure Device and Scale
Standard of Care
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cirrhosis, Liver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients will need to have decompensated cirrhosis defined as a Child Pugh Score ≥ 7 Exclusion Criteria: None

Sites / Locations

  • University of California San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Standard of Care

Home Blood Pressure and Scale Monitoring to Inform Clinical Decisions

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Mean Arterial Pressure
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
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.

Full Information

First Posted
June 23, 2023
Last Updated
September 12, 2023
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT05928624
Brief Title
A Pilot Trial to Test the Feasibility of Utilizing Home Blood Pressure Monitoring to Optimize the Administration of Midodrine Among Decompensated Cirrhosis Patients
Acronym
WATCH
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 22, 2023 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.
Detailed Description
This is a feasibility trial to determine the feasibility of using home monitoring devices (e.g. blood pressure cuffs) to improve outcomes for cirrhosis patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Liver, Portal Hypertension, Ascites Hepatic

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Home Blood Pressure and Scale Monitoring to Inform Clinical Decisions
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Withings Home Blood Pressure Device and Scale
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Standard of Care
Primary Outcome Measure Information:
Title
Change in Mean Arterial Pressure
Description
The investigators will compare the change in mean arterial pressure before and after utilization of the data generated from the home monitoring.
Time Frame
Baseline and 24 Weeks
Secondary Outcome Measure Information:
Title
Change in Ascites Burden
Description
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.
Time Frame
Baseline and 24 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients will need to have decompensated cirrhosis defined as a Child Pugh Score ≥ 7 Exclusion Criteria: None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giuseppe Cullaro, MD, MAS
Phone
415 476 3143
Email
giuseppe.cullaro@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Hannah Chao
Email
hannah.chao@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Cullaro, MD, MAS
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Cullaro, MD, MAS
Phone
415-476-3143
Email
giuseppe.cullaro@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Hannah Chao
Phone
415 476 3143
Email
hannah.chao@ucsf.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Pilot Trial to Test the Feasibility of Utilizing Home Blood Pressure Monitoring to Optimize the Administration of Midodrine Among Decompensated Cirrhosis Patients

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