Quality of Life in Non-alcoholic Fatty Liver Disease (QOLNAFLD)
Ключови думи
Резюме
Описание
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
Дати
Последна проверка: | 03/31/2020 |
Първо изпратено: | 05/16/2018 |
Очаквано записване подадено: | 07/31/2018 |
Първо публикувано: | 08/02/2018 |
Изпратена последна актуализация: | 04/01/2020 |
Последна актуализация публикувана: | 04/05/2020 |
Действителна начална дата на проучването: | 08/31/2018 |
Приблизителна дата на първично завършване: | 12/30/2020 |
Очаквана дата на завършване на проучването: | 12/30/2020 |
Състояние или заболяване
Интервенция / лечение
Other: Motivational Interviewing
Фаза
Групи за ръце
Arm | Интервенция / лечение |
---|---|
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 |
Критерии за допустимост
Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
Полове, допустими за проучване | All |
Приема здрави доброволци | Да |
Критерии | 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 |
Резултат
Първични изходни мерки
1. Health Survey 36 Short Form (SF36) [6 months]
2. Hospital Anxiety and Depression Scale (HADS) [6 months]
3. Chronic Liver Disease Questionnaire (CLDQ) [6 months]
4. Fatigue Severity Scale [6 months]
Вторични изходни мерки
1. Alanine aminotransferase levels (ALT) [6 months]
2. Aspartate aminotransferase levels (AST) [6 months]
3. Body Mass Index (BMI) [6 months]