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Behavioral Intervention
Hepatology Home Hospital for Advanced Liver Disease
N/A
Waitlist Available
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult patients ≥ 18 years old with a diagnosis of cirrhosis based on histology, radiology, and/or elastography
Admitted for symptomatic ascites
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing a home care program for people with late-stage liver disease.
Who is the study for?
This trial is for adults over 18 with advanced liver disease diagnosed through tests or scans, currently hospitalized for swelling in the abdomen due to ascites, and under care at MGH. They must be stable after a day in hospital, have phone or internet access, live within MGH's home service area, and not need intensive care.Check my eligibility
What is being tested?
The study is testing a Hepatology Home Hospital program designed to provide home-based medical care for patients with severe liver conditions. It aims to evaluate if managing these patients at home is effective and safe.See study design
What are the potential side effects?
Since this trial involves a healthcare delivery method rather than medication, traditional side effects are not applicable. However, there may be risks associated with receiving complex medical care outside of a standard hospital setting.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older and have been diagnosed with cirrhosis.
Select...
I am hospitalized for fluid buildup in my abdomen.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Enrollment Rate
Retention Rate
Secondary outcome measures
Acceptability of the intervention
Other outcome measures
Ascites-specific health-related quality of life (Ascites Questionnaire, Ascites-Q)
Caregiver Burden (Zarit Burden Interview 12, ZBI-12)
Caregiver Self-Efficacy (Family Caregiver Activation in Transitions, FCAT; Caregiver Self-Efficacy Scale, CSES-8)
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Hepatology Hospital at HomeExperimental Treatment1 Intervention
Patients with cirrhosis presenting with symptomatic ascites receive their care in the home.
Group II: Usual Hepatology CareActive Control1 Intervention
Patients with cirrhosis presenting with symptomatic ascites receive their care in the hospital, as usual.
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Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,929 Previous Clinical Trials
13,198,265 Total Patients Enrolled
8 Trials studying Liver Cirrhosis
630 Patients Enrolled for Liver Cirrhosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have hepatic encephalopathy and am on medication but don't have a caregiver.I am 18 or older and have been diagnosed with cirrhosis.I am currently in the intensive care unit.I am currently admitted for a blood clot in the liver, GI bleeding, or severe liver inflammation due to alcohol.I experience sudden, brief, nonrhythmic muscle twitches.I need help from more than one person to use the bathroom.I am hospitalized for fluid buildup in my abdomen.I have fluid in my abdomen that doesn't respond to treatment or I am on dialysis.I have a liver condition that affects my brain function.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Hepatology Care
- Group 2: Hepatology Hospital at Home
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers currently recruiting participants for this experiment?
"Unfortunately, per clinicaltrials.gov's records this test is not currently seeking participants; the trial was originally posted on September 1st 2022 and last modified on August 23rd 2022. Nevertheless, there are presently 700 other medical studies enrolling patients."
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