Quality of Life in Non-alcoholic Fatty Liver Disease (QOLNAFLD)

NCT ID: NCT03613480

Last Updated: 2022-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2022-12-01

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

Conditions

Non-Alcoholic Fatty Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Motivational Interviewing

Patients will receive 6 brief (20-30mins) counseling sessions based on the principles of Motivational Interviewing by a trained member (psychiatrist) of the research team. The first session will take place at 2 weeks after baseline and the following 5 sessions will be conducted at a monthly basis.

Group Type: EXPERIMENTAL

Motivational Interviewing

Intervention Type: OTHER

Regular sessions of Motivational Interviewing at 2 weeks and then at monthly intervals for a period of 6 months

Care as usual

Patients will be followed-up by the hepatologists of the Outpatient Department at regular time intervals and will be re-evaluated after 6 months from baseline

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Motivational Interviewing

Regular sessions of Motivational Interviewing at 2 weeks and then at monthly intervals for a period of 6 months

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Patras

OTHER

Sponsor Role: lead

Responsible Party

Christos Triantos

Assistant Professor in Internal Medicine and Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Gastroenterology

Pátrai, , Greece

Countries

Greece

Other Identifiers

328/15.05.2018

Identifier Type: -

Identifier Source: org_study_id