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

Study of Quality of Life in Patients With Non-alcoholic Fatty Liver Disease

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Other: Motivational Interviewing

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

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Patras, Greece, 26504
    • Department of Gastroenterology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Motivational Interviewing; Regular sessions of Motivational Interviewing at 2 weeks and then at monthly intervals for a period of 6 months
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Survey 36 Short Form (SF36)	The SF36 is a self-report, generic quality of life instrument, which includes eight multi-item scales (36 items) that evaluate the extent to which an individual's health limits his or her physical, emotional, and social well-being. The SF-36 covers eight domains of HRQOL, namely physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores on each subscale range from 0 to 100, with higher scores indicating a better quality of life. Sub-scales scores are calculated according to an algorithm described in the SF36 manual.	6 months
Hospital Anxiety and Depression Scale (HADS)	This is a psychometric tool measuring psychological distress. It is comprised of 14 items, 7 items for anxiety and 7 items for depression. Each item is scored from 0 to 3 and subscale scores are calculated by summing the 7 item scores. Each subscale ranges from 0-21 and higher scores indicate greater severity of depressive and anxious symptoms	6 months
Chronic Liver Disease Questionnaire (CLDQ)	This is a disease-specific instrument measuring quality of life. It encompasses 29 items contained within six domains including abdominal symptoms, fatigue, systemic symptoms, activity, emotional function and worry. A Likert scale response format is used for all items ranging from 1 (most impairment) to 7 (least impairment). Scoring of the questionnaire is performed by dividing each domain score by the number of items per domain.Overall CLDQ score is obtained by adding scores for each item and dividing by the total number of items.	6 months
Fatigue Severity Scale	This 9-item scale measures the severity of fatigue and its effect on a person's activity and lifestyle in patients with various disorders. Each item is scored on a 7 point scale with 1=strongly disagree and 7=strongly agree. Total score is calculated by adding each item score. Scores range from 9 to 63 and higher scores indicate greater fatigue severity	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alanine aminotransferase levels (ALT)	This is a blood test measuring the serum concentration of alanine aminotransferase which is elevated in liver damage. ALT reference rates range between 20 to 60 IU/L	6 months
Aspartate aminotransferase levels (AST)	This is a blood test measuring the serum concentration of aspartate aminotransferase which is elevated in liver damage. AST reference rates range between 5 to 40 IU/L	6 months
Body Mass Index (BMI)	The Body Mass Index is a measure of obesity. It is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres.Normal BMI ranges from 18.5-24.9	6 months

Collaborators and Investigators

• Sponsor: University Hospital of Patras

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): December 31, 2020
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: May 17, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Actual): June 2, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 328/15.05.2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No