Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Non Alcoholic Fatty Liver Disease
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: All eligible patients will be randomized to receive either counseling sessions or care as usualMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Introduction: The term non-alcoholic fatty liver disease (NAFLD) encompasses a spectrum of disorders ranging from simple steatosis to steatohepatitis, in the absence of other known causes of liver steatosis. NAFLD is a highly prevalent disorder which is directly linked to patients' lifestyle and is ...

Introduction: The term non-alcoholic fatty liver disease (NAFLD) encompasses a spectrum of disorders ranging from simple steatosis to steatohepatitis, in the absence of other known causes of liver steatosis. NAFLD is a highly prevalent disorder which is directly linked to patients' lifestyle and is accompanied by severe co-morbidities. Although there is a wealth of studies on NAFLD's pathogenesis, natural course and treatment, few investigations have focused on patients' quality of life (QoL) and even fewer have evaluated the impact of therapeutic interventions on patients' quality of life and psychosocial functioning. In this context, there is a significant literature gap, given that modern research and clinical practice should aim at meeting patients' subjective physical and psychosocial needs and improving their overall quality of living. Aim-Methods: In this context, the aim of the present study is to assess the effect of systematic counseling on NAFLD patients' quality of life, psychological distress, fatigue and lifestyle habits. The current study will be conducted at the Gastroenterology Department of the University Hospital of Patras with the collaboration of the Department of Psychiatry. NAFLD patients will be invited to enrol to the study after being thoroughly informed about its aim and methods. Eligible patients will be assessed at baseline and then will be randomized to receive either systematic counseling based on the principles of Motivational Interviewing or care as usual. All participants will be re-evaluated at 6 months after study initiation. In addition, all patients will be submitted to laboratory tests including complete blood count, serum albumin, hemoglobin, gamma-globulin, ALT, AST, ?GT, ALP, bilirubin, PT, INR, urea, creatinine, total cholesterol, LDL, HDL, triglycerides both at baseline and at study completion

Tracking Information

NCT #
NCT03613480
Collaborators
Not Provided
Investigators
Not Provided