Assessment of the Symptomatic Burden of Patients With Advanced Chronic Liver Disease. Correlation Between the Model for End-Stage Liver Disease (MELD)-Na and the Edmonton Symptom Assessment System Scale (ESAS).
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- MELD ESAS
Study Overview
Brief Summary
The goal of this observational study is to understand if there is a correlation between the evolution of MELD-Na and symptomatic burden of patients with advanced chronic liver disease.
All patients with chronic liver disease will be invited to participate in the study. Patients will be followed prospectively with assessment of their MELD-Na score and symptom burden, according to the Edmonton Symptom Assessment System scale.
Detailed Description
- Methodology - Prospective observational study
- Population - All patients with chronic liver disease followed in the Matosinhos Local Health Unit after their first episode of decompensation or are diagnosed with hepatocellular carcinoma in stage C or D of the Barcelona Liver Clinic Cancer will be invited to participate in the study.
All patients who do not sign consent to participate, patients under 18 years of age and patients who present a recurrent degree of encephalopathy, according to the West-Haven scale, equal or greater than 2, will be excluded. 3. Sample - Non-probabilistic for convenience 4. Data collection instrument - Patients will be followed prospectively with quarterly assessment, or after each episode of decompensation, of their MELD-Na score and symptom burden, according to the Edmonton Symptom Assessment System scale (ESAS), with introduction of 3 other symptoms prevalent in patients with chronic liver disease: sexual dysfunction sexual, cramps and pruritus. The minimum analysis for each patient will be 2 assessments.
All symptoms greater than 5 points will be considered moderate to severe and formal referral to the palliative care team will be discussed with the patient and their attending physician. Subsequently evaluating its effectiveness in symptomatic control. 5. Aims - This observational study will try to understand if there is a correlation between the evolution of MELD-Na and symptomatic burden of patients with advanced chronic liver disease. As well as the influence that the implementation of palliative care have on symptom burden of advanced chronic liver disease patients.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients with chronic liver disease
Exclusion Criteria
- •do not sign consent to participate
- •patients under 18 years of age
- •patients who present a recurrent degree of encephalopathy, according to the West-Haven scale, equal or greater than 2
Outcomes
Primary Outcomes
MELD ESAS
Time Frame: 1 year
Evaluate and correlate the evolution of MELD-Na and ESAS on advanced chronic liver disease.
Secondary Outcomes
No secondary outcomes reported
Investigators
Hugo Miguel Oliveira
Principal Investigator
Universidade do Porto
