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Behavioral Intervention

Transitional Care Program for Liver Cirrhosis

N/A
Recruiting
Led By Karen L Krok, MD
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be over 18 years of age
Hospitalized with fluid overload (ascites and/or significant anasarca/edema) requiring diuretic therapy
Must not have
Placement of a TIPS
Non-English speaking
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Summary

"This trial aims to study a monitoring program for patients with cirrhosis and excessive swelling after leaving the hospital. They want to see how much time and resources are needed to run the program, how well

Who is the study for?
This trial is for English-speaking adults over 18 with cirrhosis, hospitalized at Penn State Health with fluid overload needing diuretics. It's not suitable for those who don't meet these specific conditions.
What is being tested?
The study tests a transitional care program involving intensive monitoring after hospital discharge. This includes education, digital weight tracking, regular phone calls and follow-ups to improve health outcomes versus standard care.
What are the potential side effects?
Since this trial involves monitoring rather than medication, direct side effects are minimal. However, stress or anxiety from frequent check-ins could occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 years old.
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I am in the hospital for fluid buildup needing water pills.
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I have been diagnosed with cirrhosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a procedure to create a new pathway in my liver.
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I do not speak English.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of follow up visits
Number of instances of weight monitoring
Number of successful phone calls
+1 more
Secondary outcome measures
Number of Hospitalizations per participant
Number of subjects that continue to have volume overload
Number of subjects that develop Acute Kidney Injury
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Transitional Care ProgramExperimental Treatment1 Intervention
Participants will receive a digital scale and monitoring log, educational material, a phone call within 72 hours of discharge and weekly for 8 weeks, and a follow up appointment with a hepatologist within 4 weeks of discharge.
Group II: Standard of CareActive Control1 Intervention
Participants will be given typical discharge and follow up instructions.

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
504 Previous Clinical Trials
2,795,920 Total Patients Enrolled
Karen L Krok, MDPrincipal InvestigatorPenn State College of Medicine
~13 spots leftby Mar 2025
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