CirrhosisEarly Phase 1VivifyNCT02457988
The Cirrhosis Outpatient Optimization, Readmission & Safety Study
A Early Phase 1 study testing Vivify Kit in people with Cirrhosis, run by University of California, Los Angeles at 1 site in United States.
Trial summary
A prospective series comparing care incorporating home monitoring and liver care coordination to conventional care for patients with cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis
- What is being tested?
- Vivify Kit
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Oct 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ascites requiring paracentesis during the hospitalization
- Hepatic encephalopathy defined as altered mental status that improves after treatment with lactulose
- Variceal hemorrhage, defined as clinically significant gastrointestinal bleed (tachycardia, hypotension, requirement for blood transfusion, or >2g drop in hemoglobin) and varices seen on endoscopy
- Spontaneous bacterial peritonitis defined as >250 polymorphonuclear cells per high-power field and/or monomicrobial culture in the ascetic fluid
- Renal failure in the presence of ascites, defined as a rise in the serum creatinine by 0.5mg/dl (to >1.5mg/dl), with ascites documented on physical exam or ultrasound, or admitted on diuretics for the treatment of ascites
- Hyponatremia, defined by serum sodium <130 on admission labs
- Hepatocellular carcinoma as seen on arterial phase MRI or liver biopsy, if tumor is treated and fits within Milan criteria
Who cannot join
- Admissions for scheduled or elective procedures
- Patients with a comorbid conditions with a life expectancy of less than 12 months or ones that may confound a patient's clinical course
- Hepatocellular carcinoma
- Hepatorenal syndrome
- Hepatopulmonary syndrome
- Metastatic cancer
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- Chronic kidney disease (pre-dialysis, dialysis)
- Congestive heart failure
- Diagnosed dementia
- HIV/AIDS
- Pregnancy or planned pregnancy during the study
- Those managed by palliative care
- Patients with liver transplants prior to or during the index hospitalization
- Patients unable to understand study procedures/instructions/use of the home monitoring device
- Patients unable to stand for <1 minute
- Patients living in nursing homes or similar institutions
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Center for Inflammatory Bowel Diseases
Los Angeles, California, 90095
About this study
Official title: COORS: The Cirrhosis Outpatient Optimization, Readmission & Safety Study
A prospective series comparing care incorporating home monitoring and liver care coordination to conventional care for patients with cirrhosis.
Read the detailed description
Telemonitoring has been suggested to have potential benefits in patients with cirrhosis. However, to date, no prospective studies exist to support this idea. Hence, the investigators study would like to explore the use of home telemonitoring devices with vital sign capturing capabilities in recently-discharged patients with cirrhosis to decrease 30-day readmissions, mortality and costs.
This is prospective, randomized controlled trial comparing two strategies of post-discharged care in patients with cirrhosis-related hospitalizations.
First treatment arm will incorporate the Vivify home monitoring device into post hospital care.Home monitoring kits include a tablet with wireless internet and vital sign monitoring capabilities (temperature, blood pressure, heart rate, weight and pulse oximetry if needed) and the device has the ability to trigger an alert to the "liver care coordinator."
Second treatment arm will continue the standard of care therapy that all post- hospitalized patients receive upon discharge, i.e. return to clinic appointments, education regarding any signs or worsening symptoms to watch for, as well as contact numbers to connect with their doctor or nurse.
- Conditions
- Cirrhosis
- Being tested
- Vivify Kit
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivify KitDevice
home telemonitoring devices with vital sign capturing capabilities, i.e. blood pressure, weight, pulse, and specific questionnaires targeted to the cirrhosis diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Vivify Kit | Experimental | Patients with cirrhosis will undergo home monitoring for 30 days post-discharge through the use of the Vivify kit which contains a wireless tablet with daily medication/diet/symptom questionnaires and vital sign monitoring. Receives: Device: Vivify Kit |
| Standard of Care | No intervention | Patients with cirrhosis will undergo standard of care, which includes a post-discharge lab check and follow-up clinic appointment. Otherwise, no day-to-day monitoring of these patients will occur. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of 30-day readmissions between intervention and control group
Compare hospital readmission rates between the intervention group (device) and control group
Measured: 30 days
Secondary outcomes (4)
Number of emergency room visits between the two study groups for ED visits within 30 days post discharge. (composite measure)
Number of ED visits will be measured and compared for both of the groups
Measured: 30 days
Blood pressure control
Overall control of blood pressure between the two groups will be compared
Measured: 30 days
Weight compliance
Weight changes will be monitored and compared between two groups
Measured: 30 days
Medication compliance
Medication compliance will be monitored and compared between two groups
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startApr 2015
- Primary completionOct 2017
- Study completionOct 2017
Why it stopped: Increased recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel W Hommes, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457988
- Sponsor's protocol ID
- COORS
- Acronym
- Vivify
- Status last verified
- Oct 2017
- First submitted
- 25 Feb 2015
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Volk ML, Tocco RS, Bazick J, Rakoski MO, Lok AS. Hospital readmissions among patients with decompensated cirrhosis. Am J Gastroenterol. 2012 Feb;107(2):247-52. doi: 10.1038/ajg.2011.314. Epub 2011 Sep 20.
PubMed 21931378Berman K, Tandra S, Forssell K, Vuppalanchi R, Burton JR Jr, Nguyen J, Mullis D, Kwo P, Chalasani N. Incidence and predictors of 30-day readmission among patients hospitalized for advanced liver disease. Clin Gastroenterol Hepatol. 2011 Mar;9(3):254-9. doi: 10.1016/j.cgh.2010.10.035. Epub 2010 Nov 17.
PubMed 21092762
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COORS: The Cirrhosis Outpatient Optimization, Readmission & Safety Study
- ClinicalTrials.gov ID
- NCT02457988
- Acronym / sponsor ID
- Vivify / COORS
- Conditions
- Cirrhosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Increased recruitment difficulties
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 29 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective series comparing care incorporating home monitoring and liver care coordination to conventional care for patients with cirrhosis.
Detailed description
Telemonitoring has been suggested to have potential benefits in patients with cirrhosis. However, to date, no prospective studies exist to support this idea. Hence, the investigators study would like to explore the use of home telemonitoring devices with vital sign capturing capabilities in recently-discharged patients with cirrhosis to decrease 30-day readmissions, mortality and costs.
This is prospective, randomized controlled trial comparing two strategies of post-discharged care in patients with cirrhosis-related hospitalizations.
First treatment arm will incorporate the Vivify home monitoring device into post hospital care.Home monitoring kits include a tablet with wireless internet and vital sign monitoring capabilities (temperature, blood pressure, heart rate, weight and pulse oximetry if needed) and the device has the ability to trigger an alert to the "liver care coordinator."
Second treatment arm will continue the standard of care therapy that all post- hospitalized patients receive upon discharge, i.e. return to clinic appointments, education regarding any signs or worsening symptoms to watch for, as well as contact numbers to connect with their doctor or nurse.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vivify Kit | Experimental | Device: Vivify KitPatients with cirrhosis will undergo home monitoring for 30 days post-discharge through the use of the Vivify kit which contains a wireless tablet with daily medication/diet/symptom questionnaires and vital sign monitoring. |
| Standard of Care | No intervention | –Patients with cirrhosis will undergo standard of care, which includes a post-discharge lab check and follow-up clinic appointment. Otherwise, no day-to-day monitoring of these patients will occur. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ascites requiring paracentesis during the hospitalization
- Hepatic encephalopathy defined as altered mental status that improves after treatment with lactulose
- Variceal hemorrhage, defined as clinically significant gastrointestinal bleed (tachycardia, hypotension, requirement for blood transfusion, or >2g drop in hemoglobin) and varices seen on endoscopy
- Spontaneous bacterial peritonitis defined as >250 polymorphonuclear cells per high-power field and/or monomicrobial culture in the ascetic fluid
- Renal failure in the presence of ascites, defined as a rise in the serum creatinine by 0.5mg/dl (to >1.5mg/dl), with ascites documented on physical exam or ultrasound, or admitted on diuretics for the treatment of ascites
Key exclusion criteria (16 listed)
- Admissions for scheduled or elective procedures
- Patients with a comorbid conditions with a life expectancy of less than 12 months or ones that may confound a patient's clinical course
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vivify Kithome telemonitoring devices with vital sign capturing capabilities, i.e. blood pressure, weight, pulse, and specific questionnaires targeted to the cirrhosis diagnosis. | Device | Vivify Kit |
Primary outcome
Number of 30-day readmissions between intervention and control group
Time frame: 30 days
Compare hospital readmission rates between the intervention group (device) and control group
4 secondary outcomes
Number of emergency room visits between the two study groups for ED visits within 30 days post discharge. (composite measure)
Time frame: 30 days
Blood pressure control
Time frame: 30 days
Weight compliance
Time frame: 30 days
Medication compliance
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Increased recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Background: PubMed 21931378Volk ML, Tocco RS, Bazick J, Rakoski MO, Lok AS. Hospital readmissions among patients with decompensated cirrhosis. Am J Gastroenterol. 2012 Feb;107(2):247-52. doi: 10.1038/ajg.2011.314. Epub 2011 Sep 20.
- Background: PubMed 21092762Berman K, Tandra S, Forssell K, Vuppalanchi R, Burton JR Jr, Nguyen J, Mullis D, Kwo P, Chalasani N. Incidence and predictors of 30-day readmission among patients hospitalized for advanced liver disease. Clin Gastroenterol Hepatol. 2011 Mar;9(3):254-9. doi: 10.1016/j.cgh.2010.10.035. Epub 2010 Nov 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel W Hommes, MD, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vivify Kit in people with Cirrhosis, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Increased recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of 30-day readmissions between intervention and control group (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02457988, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.