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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of follow up visits

Number of instances of weight monitoring

Number of successful phone calls

+1 more

Secondary study objectives

Number of Hospitalizations per participant

Number of subjects that continue to have volume overload

Number of subjects that develop Acute Kidney Injury

+1 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: 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.

0 / 5Eligibility criteria met