Non-Alcoholic Fatty Liver Disease Clinical Trial
— QOLNAFLDOfficial title:
Study of Quality of Life in Patients With Non-alcoholic Fatty Liver Disease
Verified date | May 2022 |
Source | University Hospital of Patras |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | December 1, 2022 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Greece | Department of Gastroenterology | Patras |
Lead Sponsor | Collaborator |
---|---|
University Hospital of Patras |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 |
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