Factors Associated With End Stage Liver Disease
| Status: | Terminated |
|---|---|
| Conditions: | Depression, Other Indications, Neurology, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Neurology, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | July 2012 |
| End Date: | December 2016 |
100 ambulatory cirrhotic patients attending a liver transplant clinic will undergo a
comprehensive clinical evaluation for severity of liver disease, anemia, depression, and
fatigue. Fatigue will be assessed with the FIS and sub-maximal exercise capacity with the
6-minute walk test (6MWT), a standardized exercise test that measures the distance that a
patient is capable of walking in 6 minutes (6MWD). Depression will be assessed by using
three well-known questionnaires. The SF-36, Beck's Depression Inventory (BDI-II), EQ-5D, and
the Psychological General Well-Being Index (PGWBI). Univariate analysis will be performed to
select the factors that potentially are associated with the scores as indicated by a P value
<.20; the selected factors will then be entered in a stepwise regression to create a
multivariate model giving the combination of factors that are significantly associated with
the measure of fatigue and depression. Hemoglobin (Hb) levels will then be added to the
model in order to test its significance while controlling for the other factors.
comprehensive clinical evaluation for severity of liver disease, anemia, depression, and
fatigue. Fatigue will be assessed with the FIS and sub-maximal exercise capacity with the
6-minute walk test (6MWT), a standardized exercise test that measures the distance that a
patient is capable of walking in 6 minutes (6MWD). Depression will be assessed by using
three well-known questionnaires. The SF-36, Beck's Depression Inventory (BDI-II), EQ-5D, and
the Psychological General Well-Being Index (PGWBI). Univariate analysis will be performed to
select the factors that potentially are associated with the scores as indicated by a P value
<.20; the selected factors will then be entered in a stepwise regression to create a
multivariate model giving the combination of factors that are significantly associated with
the measure of fatigue and depression. Hemoglobin (Hb) levels will then be added to the
model in order to test its significance while controlling for the other factors.
100 ambulatory patients with cirrhosis will be prospectively evaluated for severity of liver
disease, anemia, and fatigue; exclusion criteria includes chronic renal insufficiency and
recent alcohol use, gastrointestinal bleeding, and infection.
Patients will first be identified and be asked to partake in the study. They will be asked
to read over an informed consent form. Subsequently, they will be asked to fill out a
depression questionnaire before performing the 6MWT. During the 6MWT the patient will be
walking up and down two designated points 100 feet apart. They will be asked to walk for 6
minutes using any walking aids and resting as needed. Their final distance will be recorded.
They will then be asked to fill out the FIS fatigue questionnaire.
Severity of liver disease will be assessed through a detailed clinical examination of
ascites grade, hepatic encephalopathy, history of complications from cirrhosis (hepatic
coma, spontaneous bacterial peritonitis, gastrointestinal bleeding), standard liver tests
(TBili, Albumin, INA), platelet count as a parameter of splenic sequestration and portal
hypertension, Child-Pugh score, MELD (Model of End-stage Liver Disease) score. Anemia will
be assessed with hemoglobin levels. Depression will be assessed with the following
questionnaires: Beck Depression Inventory (BDI), EQ-5D, Psychological General Well-Being
Index (PGWBI), LDQOL. Fatigue will be assessed with the FIS and 6 Minute Walk Test. Hepatic
Encephalopathy will be assessed with the number connection, digit-symbol coding and
inhibitory control test. Sexual function will be assessed by the Sexual Problems and Sexual
Function scales of the LDQOL. The results will be scored and compared to depression quality
of life, and end-stage liver disease factors.
disease, anemia, and fatigue; exclusion criteria includes chronic renal insufficiency and
recent alcohol use, gastrointestinal bleeding, and infection.
Patients will first be identified and be asked to partake in the study. They will be asked
to read over an informed consent form. Subsequently, they will be asked to fill out a
depression questionnaire before performing the 6MWT. During the 6MWT the patient will be
walking up and down two designated points 100 feet apart. They will be asked to walk for 6
minutes using any walking aids and resting as needed. Their final distance will be recorded.
They will then be asked to fill out the FIS fatigue questionnaire.
Severity of liver disease will be assessed through a detailed clinical examination of
ascites grade, hepatic encephalopathy, history of complications from cirrhosis (hepatic
coma, spontaneous bacterial peritonitis, gastrointestinal bleeding), standard liver tests
(TBili, Albumin, INA), platelet count as a parameter of splenic sequestration and portal
hypertension, Child-Pugh score, MELD (Model of End-stage Liver Disease) score. Anemia will
be assessed with hemoglobin levels. Depression will be assessed with the following
questionnaires: Beck Depression Inventory (BDI), EQ-5D, Psychological General Well-Being
Index (PGWBI), LDQOL. Fatigue will be assessed with the FIS and 6 Minute Walk Test. Hepatic
Encephalopathy will be assessed with the number connection, digit-symbol coding and
inhibitory control test. Sexual function will be assessed by the Sexual Problems and Sexual
Function scales of the LDQOL. The results will be scored and compared to depression quality
of life, and end-stage liver disease factors.
Inclusion Criteria:
- male or female, age b/w 18-70 years, inclusive
- willingly and able to provide written consent
- Diagnosed with Cirrhosis
- Able to read and write in English
Exclusion Criteria:
- Inability to provide consent
- Not within age range of 18-70 years, inclusive
- Not diagnosed with Cirrhosis
- Unable to read or write in English
- Unable to walk
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