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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
Must not have
Have a current diagnosis of hepatic encephalopathy on medical therapy and do not have a caregiver at home
Are admitted to the intensive care unit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I am 18 or older and have been diagnosed with cirrhosis.
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I am hospitalized for fluid buildup in my abdomen.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have hepatic encephalopathy and am on medication but don't have a caregiver.
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I am currently in the intensive care unit.
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I am currently admitted for a blood clot in the liver, GI bleeding, or severe liver inflammation due to alcohol.
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I experience sudden, brief, nonrhythmic muscle twitches.
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I need help from more than one person to use the bathroom.
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I have fluid in my abdomen that doesn't respond to treatment or I am on dialysis.
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I have a liver condition that affects my brain function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Enrollment Rate
Retention Rate
Secondary study objectives
Acceptability of the intervention
Other study objectives
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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,015 Previous Clinical Trials
13,309,320 Total Patients Enrolled

Media Library

Hepatology Home Hospital (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05205954 — N/A
Non-invasive Indices to Predict Hepatic Fibrosis in BA Patients. Research Study Groups: Usual Hepatology Care, Hepatology Hospital at Home
Non-invasive Indices to Predict Hepatic Fibrosis in BA Patients. Clinical Trial 2023: Hepatology Home Hospital Highlights & Side Effects. Trial Name: NCT05205954 — N/A
Hepatology Home Hospital (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05205954 — N/A
~11 spots leftby Feb 2025
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