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

NCT03613480 | Unknown

• 1 other identifier: 328/15.05.2018
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Alanine aminotransferase levels (ALT)

  6 months

• Aspartate aminotransferase levels (AST)

  6 months

• Body Mass Index (BMI)

  6 months

Study Arms (2)

Motivational Interviewing

EXPERIMENTAL

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

Care as usual

NO INTERVENTION

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

Interventions

Motivational Interviewing OTHER

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

Motivational Interviewing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Patras: lead

Study Sites (1)

Department of Gastroenterology

Pátrai, 26504, Greece

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Internal Medicine and Gastroenterology

Model Details: All eligible patients will be randomized to receive either counseling sessions or care as usual

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: August 3, 2018
• Study Start: September 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 1, 2022
• Last Updated: June 2, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)