Clinical trial NCT03613480: Quality of Life in Non-alcoholic Fatty Liver Disease (QOLNAFLD)
Official title: Study of Quality of Life in Patients With Non-alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Lead sponsor: University Hospital of Patras
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All eligible patients will be randomized to receive either counseling sessions or care as usual
Primary purpose: TREATMENT

Brief summary: Non-alcoholic fatty liver disease (NAFLD) is a highly prevalent disorder which is directly linked to lifestyle patterns and is associated with poor quality of life, increased fatigue and psychological distress. The aim of the current study is to evaluate quality of life, fatigue and psychological functioning in NAFLD patients and assess the impact of systematic counseling on patients' psychosocial functioning.

Detailed 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 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, γGT, ALP, bilirubin, PT, INR, urea, creatinine, total cholesterol, LDL, HDL, triglycerides both at baseline and at study completion

Eligibility criteria: Inclusion Criteria:

• Non-alcoholic fatty liver disease according to the EASL-EASD-EASO Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease

Exclusion Criteria:

* Chronic viral hepatitis or any other severe chronic liver disease
* Major psychopathology
* Severe cognitive or neurological deficits
* Cancer or any other severe chronic disease not associated with NAFLD
* Inadequate knowledge of the Greek language

Primary outcomes:
measure: Health Survey 36 Short Form (SF36)
timeFrame: 6 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 6 months
measure: Chronic Liver Disease Questionnaire (CLDQ)
timeFrame: 6 months
measure: Fatigue Severity Scale
timeFrame: 6 months
Secondary outcomes:
measure: Alanine aminotransferase levels (ALT)
timeFrame: 6 months
measure: Aspartate aminotransferase levels (AST)
timeFrame: 6 months
measure: Body Mass Index (BMI)
timeFrame: 6 months
Other outcomes:
Locations:
city: Patras
country: Greece
facility: Department of Gastroenterology
Study officials:
References: