Cirrhosis of the Liver
Conditions
Keywords
Cirrhosis of the liver, Pre-liver transplant Candidate, Depression, Poor social support, Liver disease symptoms, Health releated quality of life
Brief summary
The purpose of this study is to describe the HRQoL in those with MELD scores \</= 15 in a single center for those who are pre-liver transplant candidates
Detailed description
The liver organ allocation system was significantly revised in 2002, allowing a more objective prioritization of liver transplant candidates. The revised Model for End Stage Liver Disease (MELD) system is based primarily on laboratory test results. Candidates with MELD scores of less than 15 are considered to be low priority for cadaveric liver transplant and have limited treatment options. Yet patients with low MELD scores may suffer from an array of symptoms associated with liver disease such as fatigue, sleep disturbances, and depression - all of which erode health-related quality of life (HRQoL). No previous studies were found that examined HRQoL in low MELD transplant patients. A better understanding of the HRQoL of these patients will allow clinicians to better meet their needs. Therefore, the aims of the proposed pilot capstone project are to examine HRQoL and to identify demographic and clinical characteristics including liver-disease related symptoms, functional status, perceived social support, biological functioning and mental health associated with HRQoL in pre-liver transplant candidates with low MELD scores. The revised Wilson and Cleary Quality of Life Model will be used to guide the project. Fifty pre-transplant liver candidates with MELD scores \< 15 will be enrolled in the descriptive, cross-sectional pilot study. Participants will complete a written questionnaire measuring perceived HRQoL and clinical characteristics. Descriptive and correlational statistics will be used to analyze the data. Findings from this project will identify trends in factors that contribute to a HRQoL of this population and provide the foundation for a larger future project.
Interventions
None listed
Sponsors
Loyola University
Northwestern University
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Must be a patient in the liver transplant clinic at Northwestern Memorial Hospital or one of its satellite clinics (including Washington, Illinois; Portage, Indiana; Glenview, Illinois, Oakbrook, Illinois; Joliet, Illinois) 2. Adult patient between the ages of 18-75 3. Ability to read and speak English 4. Must be a candidate for liver transplant per Northwestern Memorial Hospital liver transplant multidisciplinary committee 5. Model for End Stage Liver Disease (MELD) score ≤15 6. Cognitive ability to complete measures
Exclusion criteria
1. Non-English speaking 2. Those who have already received a liver transplant 3. Hepatic encephalopathy as evidenced by: 1. Grade II or more West Haven Criteria or Adapted West Haven Criteria 2. Evidence of Asterixis upon exam at time of consent (if consented in person) 4. Acute liver failure as etiology for liver disease. 5. MELD score \> 15 6. Mental retardation or cognitive disabilities preventing completion of the written questionnaire
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived HRQoL Score. Overall Qualty of Life Index Tool Was Utilized. | 2-3 months | Describe perceived HRQoL in patients with low MELD scores (≤15) pre-liver transplant patient population. Overall Qualty of Life Index tool was utilized. The subscales were not utilized. The unit of measurement was scores on a scale. QLI tool has a range of 0-30 for total possible score. With the higher the score the higher the HRQoL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Depressive Scores Who Had a Poor HRQoL | 2-3 months | Identify clinical characteristics such as environmental factors, patient biology, liver-disease related symptoms, functional status, general health perception, characteristics of the individual associated with perceived HRQoL in patients with low MELD scores (≤15) pre-transplant. What characteristics were found to be predictive of poor HRQoL. Tools utilized each assessed the specific variables including patient biology, liver disease symptoms, functional status, general health perception, and characteristics of the individual. |
Participant flow
Recruitment details
50 Subjects were recruited from NMH clinic and satellite clinics. Recruitement was from 03/29/12 to 06/19/12
Participants by arm
| Arm | Count |
|---|---|
| Study Popoulation There was only one group as this was a descriptive prospective study | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Study Popoulation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 42 Participants |
| Age, Continuous | 56.26 years STANDARD_DEVIATION 10.774 |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
Perceived HRQoL Score. Overall Qualty of Life Index Tool Was Utilized.
Describe perceived HRQoL in patients with low MELD scores (≤15) pre-liver transplant patient population. Overall Qualty of Life Index tool was utilized. The subscales were not utilized. The unit of measurement was scores on a scale. QLI tool has a range of 0-30 for total possible score. With the higher the score the higher the HRQoL.
Time frame: 2-3 months
Population: Entire study population was analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Popoulation | Perceived HRQoL Score. Overall Qualty of Life Index Tool Was Utilized. | 20.19 scores on a scale | Standard Deviation 5.98 |
Secondary
Percentage of Subjects With Depressive Scores Who Had a Poor HRQoL
Identify clinical characteristics such as environmental factors, patient biology, liver-disease related symptoms, functional status, general health perception, characteristics of the individual associated with perceived HRQoL in patients with low MELD scores (≤15) pre-transplant. What characteristics were found to be predictive of poor HRQoL. Tools utilized each assessed the specific variables including patient biology, liver disease symptoms, functional status, general health perception, and characteristics of the individual.
Time frame: 2-3 months
Population: Entire study population was analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Popoulation | Percentage of Subjects With Depressive Scores Who Had a Poor HRQoL | 78 percentage of participants |