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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Sham Comparator | 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. |
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| Home Blood Pressure and Scale Monitoring to Inform Clinical Decisions | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Withings Home Blood Pressure Device and Scale | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 24 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Cullaro, MD, MAS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Home Blood Pressure and Scale Monitoring to Inform Clinical Decisions |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2023 |
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| Standard of Care | Other | Standard of Care |
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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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Mean Arterial Pressure (MAP) in mmHg | Mean | Standard Deviation | mmHg |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline and 24 Weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | L | Baseline and 24 Weeks |
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These were measured over the study period, 24 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 34 | 0 | 34 | 0 | 34 |
| EG001 | 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. | 0 | 35 | 0 | 35 | 0 | 35 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Giuseppe Cullaro, MD MAS | Columbia University | 8454067438 | gc2576@cumc.columbia.edu |
| Jul 2, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014894 | Weights and Measures |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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