NCT02457988

Brief Summary

A prospective series comparing care incorporating home monitoring and liver care coordination to conventional care for patients with cirrhosis.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Apr 2015

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 29, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

December 22, 2025

Status Verified

October 1, 2017

Enrollment Period

2.5 years

First QC Date

February 25, 2015

Last Update Submit

December 16, 2025

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Number of 30-day readmissions between intervention and control group

    Compare hospital readmission rates between the intervention group (device) and control group

    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)

    30 days

  • Blood pressure control

    30 days

  • Weight compliance

    30 days

  • Medication compliance

    30 days

Study Arms (2)

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.

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.

Interventions

Vivify KitDEVICE

home telemonitoring devices with vital sign capturing capabilities, i.e. blood pressure, weight, pulse, and specific questionnaires targeted to the cirrhosis diagnosis.

Vivify Kit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Center for Inflammatory Bowel Diseases

Los Angeles, California, 90095, United States

Location

Related Publications (2)

  • 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.

    PMID: 21931378BACKGROUND

  • Berman 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.

    PMID: 21092762BACKGROUND

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel W Hommes, MD, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2015

First Posted

May 29, 2015

Study Start

April 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

December 22, 2025

Record last verified: 2017-10

Locations

US(1)