Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06181474
Status:
RECRUITING
Last Update Posted:
2024-03-05
First Post:
2023-12-12
Brief Title:
MELD ESAS Evolution Assessment of the Symptomatic Burden of Patients With Advanced Chronic Liver Disease
Sponsor:
Unidade Local de Saúde de Matosinhos EPE
Organization:
Unidade Local de Saúde de Matosinhos EPE
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MELDESAS
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
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:
1 Methodology - Prospective observational study
2 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
2 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None