Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT04581369
Eligibility Criteria:
Inclusion Criteria for patients:
* Age ≥18 years
* Cirrhosis based on:
* biopsy
* characteristic clinical, laboratory, and imaging findings
* Decompensated cirrhosis as denoted by either:
* active ascites requiring paracentesis during hospitalization or
* active overt hepatic encephalopathy requiring lactulose during hospitalization
* Poor quality of life as defined by:
* SF-36 Physical and/or Mental Component Summary scale \<40 (1SD below the mean of healthy subjects)
* Discharged to home, skilled nursing facility, sub-acute rehabilitation care, or long-term acute care
* Able to be consented, either in person or through legally authorized representative
* Access to a telephone
Inclusion criteria for caregivers:
* Age ≥18 years
* Identified caregiver of patient
* Able to be consented, either in person or through legally authorized representative
* Access to a telephone
Exclusion Criteria for patients:
* Solid organ transplant of any organ
* Life expectancy of less than 6 months
* Anticipated liver transplant within 6 months
* History of dementing illnesses and other neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, or vascular dementia
* Unable to complete study questionnaire due to hearing loss
* Legally blind
* Pregnant or nursing
* Incarcerated
* Concurrent enrollment in a related interventional research study
Exclusion criteria for caregivers:
* Impaired cognitive function
* Unable to complete study questionnaire due to hearing loss
* Legally blind
* Incarcerated
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04581369
Study Brief:
Protocol Section:
NCT04581369