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| Name | Class |
|---|---|
| Loyola University | OTHER |
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The purpose of this study is to describe the HRQoL in those with MELD scores \
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2-3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Non-English speaking
Those who have already received a liver transplant
Hepatic encephalopathy as evidenced by:
Acute liver failure as etiology for liver disease.
MELD score > 15
Mental retardation or cognitive disabilities preventing completion of the written questionnaire
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Adults who are a candidate for a liver transplant at Northwester Memorial Hospital with MELD score \
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Duke, MSN | Northwestern University | Principal Investigator |
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50 Subjects were recruited from NMH clinic and satellite clinics. Recruitement was from 03/29/12 to 06/19/12
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Popoulation | There was only one group as this was a descriptive prospective study. They all completed identical questionnaires including the Quality of Life Index, the Short-form Liver Disease Quality of Life tool, the Medical Outcomes Study Social Support Survey, the demographic tool and the Center for Epidemiological Studies Depression tool. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Popoulation | There was only one group as this was a descriptive prospective study |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Entire study population was analyzed | Posted | Mean | Standard Deviation | scores on a scale | 2-3 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Popoulation | There was only one group as this was a descriptive prospective study |
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The small sample size and convenience sampling were limitations of this study. Additionally, since subjects were recruited from only one site, generalizability of findings is limited.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Duke DNP, MSN, NP-BC Transplant Surgery Nurse Practitioner | Northwestern Memorial Hospital | 3126951686 | rduke@nmh.org |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D003863 | Depression |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| 2-3 months |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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. | Entire study population was analyzed | Posted | Number | percentage of participants | 2-3 months |
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| 50 |
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| 50 |
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