Home Blood Pressure Monitoring for Liver Cirrhosis

(WATCH Trial)

Overseen By Hannah Chao

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial uses home blood pressure monitors to help manage decompensated cirrhosis, a condition where the liver is significantly damaged. The goal is to determine if regular home monitoring can improve patient care. Participants will either share their blood pressure and weight data with their doctor to guide treatment decisions or use the devices without data sharing. The trial seeks individuals with decompensated cirrhosis, which typically involves severe liver issues affecting daily life. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance care for those with severe liver conditions.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this home blood pressure monitoring is safe for liver cirrhosis patients?

Research shows that the Withings Home Blood Pressure Device and Scale are safe to use. Studies have found that these devices accurately track health data like blood pressure and weight, simplifying home health monitoring. Millions have used Withings devices without major safety issues, and they are designed for ease of use and reliability.

Although this trial does not specifically test the devices' safety, their widespread use in other health settings supports their safety. No reports of serious problems have emerged from using these devices, indicating they are generally well-tolerated. Overall, Withings devices are considered safe and effective for home health tracking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how real-time data from home monitoring devices could transform the management of liver cirrhosis. Unlike current standard practices, which often rely on intermittent clinical visits for blood pressure tracking, this approach allows for continuous home-based monitoring. The unique aspect is that the data from the Withings devices can be shared directly with healthcare providers, potentially leading to more timely and informed clinical decisions. This could improve patient outcomes by allowing for quicker adjustments in treatment plans, offering a more personalized and proactive approach to managing liver cirrhosis.

What evidence suggests that using a home blood pressure device is effective for managing liver cirrhosis?

Research has shown that Withings home blood pressure monitors and scales can help manage health issues like high blood pressure. One study involving 3,377 patients demonstrated significant improvements in blood pressure control with these devices. Users reported high satisfaction, with 88% finding the blood pressure monitor and scale useful. The devices collect accurate information, aiding healthcare providers in making informed decisions. In this trial, one group will receive a home blood pressure monitor and scale, with data reviewed weekly and shared with the treating provider to guide clinical decisions. Although this study focuses on severe liver disease, these findings suggest that remote health tracking can effectively manage various conditions. ^{1 3 6 7 8}

Who Is on the Research Team?

Giuseppe Cullaro, MD, MAS

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for patients with advanced liver cirrhosis (Child Pugh Score ≥ 7), which means their liver is severely scarred and not working well. The study aims to help manage their condition using home blood pressure monitoring.

Inclusion Criteria

My liver disease is severe, with a Child Pugh Score of 7 or higher.

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use home blood pressure monitors and scales to inform clinical decisions

24 weeks

Weekly data review

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Withings Home Blood Pressure Device and Scale

Trial Overview The trial is testing if using a Withings Home Blood Pressure Device and Scale can improve the treatment of decompensated cirrhosis compared to standard care alone. It's a randomized single-blind study, meaning some patients will use the device while others won't, and they won't know which group they're in.

How Is the Trial Designed?

Group I: Home Blood Pressure and Scale Monitoring to Inform Clinical Decisions Experimental Treatment 1 Intervention

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.

Group II: Standard of Care Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Citations

1. withingshealthsolutions.com withingshealthsolutions.com/withings-remote-patient-monitoring-program-an-outcome-analysis-on-hypertension/

Withings Remote Patient Monitoring Program The study evaluates the effectiveness of Withings RPM programs on managing hypertension, involving 3377 patients across 50 programs, ...

2. withingshealthsolutions.com withingshealthsolutions.com/new-research-home-health-devices-reexamine-relationship-between-weight-health/

New Research Using Home Health Devices Underscores the ... These insights are derived from an extensive analysis of data from 3.4 million anonymized Withings scale users aged between 20 and 79 years old. Withings has ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7163406/

Effect of Smartphone-Enabled Health Monitoring Devices ... Satisfaction with individual devices was 88% for the BP monitor, 88% for the weight scale, 4% for the step counter, and 89% for the ECG device.

4. withings.com withings.com/us/en/research/publication_type/validation%20study?srsltid=AfmBOooleFtpG6I9V6U9sjc86HBDUyZV9hrEUsjkwfiPlF08UQ99msa5

Research | Withings USA The Withings ecosystem allows you to track a wide range of data with medical-grade accuracy. From step count to pulse wave velocity, Withings devices provide ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12290354/

A Mixed-Methods Evaluation of a Primary Care Remote ... In this manuscript we share our mixed methods analysis of the outcomes associated with our RBPM program including several clinical effectiveness ...

6. withings.com withings.com/us/en/research/publication_type/validation%20study?srsltid=AfmBOorTsXhpcdQBlGsE9TnwTiVUAB9bNf6A5gQsAsuU9_vKmPkO-TZI

Research | Withings USA The Withings ecosystem allows you to track a wide range of data with medical-grade accuracy. From step count to pulse wave velocity, Withings devices provide ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10479582/

as a case illustration, the Withings toolkit health sensing tools New home-used, self-operated, connected medical devices offer convenient and new tools for monitoring in a fully automated and ambulatory mode CKD5D patients.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8222185/

Patient-centered mobile health technology intervention to ... The main outcome of interest is adherence to HF self-care assessed objectively through time-stamped data from the electronic devices and also via patient self- ...