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Behavioral Intervention

Palliative Care for Advanced Liver Disease (LiverPAL Trial)

N/A
Recruiting
Led By Nneka Ufere, MD MSCE
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at least 12 months after patient death, up to 60 months
Awards & highlights
No Placebo-Only Group

Summary

This trial seeks to help hospitalized patients with AdvLD by integrating palliative care to improve their quality of life, physical symptoms, mood, and communication.

Who is the study for?
This trial is for English-speaking patients hospitalized with advanced liver disease, which includes conditions like overt hepatic encephalopathy (needing medication), ascites (requiring water pills or repeated fluid removal procedures), hepatic hydrothorax (needing water pills), variceal bleeding (one or more episodes), and spontaneous bacterial peritonitis.
What is being tested?
LiverPAL is being tested to see if starting palliative care early for hospitalized patients with serious liver diseases can help improve their quality of life, ease physical symptoms, better their mood, and enhance communication about their illness.
What are the potential side effects?
Since LiverPAL involves palliative care rather than a drug intervention, side effects are not the typical focus. However, it may involve emotional or psychological impacts as patients discuss and cope with serious illness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at least 12 months after patient death, up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at least 12 months after patient death, up to 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Patient Quality of Life (Functional Assessment of Chronic Illness Therapy - Palliative Care, FACIT-Pal) up t0 4 weeks
Secondary study objectives
Documentation of Patient End-of-Life (EOL) Care Preferences
Patient Anxiety Symptoms (Hospital Anxiety and Depression Scale, HADS-A)
Patient Depression Symptoms (Hospital Anxiety and Depression Scale, HADS-D)
+3 more
Other study objectives
Caregiver Anxiety Symptoms (Hospital Anxiety and Depression Scale, HADS-A) between study arms.
Caregiver Burden (Zarit Burden Index 12, ZBI-12)
Caregiver Coping (Brief COPE)
+15 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: Usual Hepatology Care with Early Palliative CareExperimental Treatment1 Intervention
Usual hepatology care with early palliative care
Group II: Usual Hepatology CareActive Control1 Intervention
Usual hepatology care

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,015 Previous Clinical Trials
13,309,160 Total Patients Enrolled
10 Trials studying Liver Cirrhosis
570 Patients Enrolled for Liver Cirrhosis
Nneka Ufere, MD MSCEPrincipal InvestigatorMassachusetts General Hospital

Media Library

LiverPAL (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05998330 — N/A
Liver Cirrhosis Research Study Groups: Usual Hepatology Care, Usual Hepatology Care with Early Palliative Care
Liver Cirrhosis Clinical Trial 2023: LiverPAL Highlights & Side Effects. Trial Name: NCT05998330 — N/A
LiverPAL (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05998330 — N/A
~133 spots leftby Jul 2027
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