Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to learn about an intensive monitoring plan (transitional care program) in patients with cirrhosis and excessive swelling that are going to be discharged from the hospital.
The main question[s] it aims to answer are:
Participants will
Researchers will compare participants in this program to patients that receive normal care to see if there are differences in need for hospitalization later, kidney injury, fluid control, and/or survival.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transitional Care Program | Experimental | 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. |
|
| Standard of Care | No Intervention | Participants will be given typical discharge and follow up instructions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transitional Care Program | Behavioral | Intensive monitoring post discharge for cirrhosis and fluid overload |
|
| Measure | Description | Time Frame |
|---|---|---|
| feasibility of the program | how much time does it take to review material and complete phone calls | all 8 weeks of each participant |
| Number of instances of weight monitoring | at home monitoring weight | 8 weeks for each participant |
| Number of successful phone calls | weekly phone call with participant | 8 weeks for each participant |
| Number of follow up visits | lab visits, primary care visits, hepatology visits | 8 weeks for each participant |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Hospitalizations per participant | number of admissions to the hospital | 12 months |
| Number of subjects that develop Acute Kidney Injury | Creatinine increase of >0.3g/dL |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen L Krok, MD | Contact | 7175311017 | kkrok@pennstatehealth.psu.edu | |
| Shannon F Dalessio | Contact | 7175310003 | 320883 | sdalessio@pennstatehealth.psu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Karen L Krok, MD | Penn State College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Milton S. Hershey Medical Center | Recruiting | Hershey | Pennsylvania | 17033 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D001201 | Ascites |
| D004487 | Edema |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 12 months |
| Number of subjects that continue to have volume overload | persistent weight above dry weight and/or ongoing ascites/lower extremity edema/pleural effusion | 12 months |
| Number of subjects that expire | subject death | 12 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |