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

November 27, 2023 updated by: University of California, San Francisco

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mean Arterial Pressure
Time Frame: 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.
Baseline and 24 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Ascites Burden
Time Frame: 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.
Baseline and 24 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

June 23, 2023

First Submitted That Met QC Criteria

June 30, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-36046

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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