Non-Alcoholic Fatty Liver DiseaseQOLNAFLDNCT03613480
Quality of Life in Non-alcoholic Fatty Liver Disease (QOLNAFLD)
A study testing Motivational Interviewing in people with Non-Alcoholic Fatty Liver Disease, run by University Hospital of Patras at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Motivational Interviewing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 1 Sep 2018to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-alcoholic fatty liver disease according to the EASL-EASD-EASO Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Motivational Interviewing
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingOther
Regular sessions of Motivational Interviewing at 2 weeks and then at monthly intervals for a period of 6 months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 6 months
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start1 Sep 2018
- Primary completion31 Dec 2020
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All eligible patients will be randomized to receive either counseling sessions or care as usual
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christos Triantos, University Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613480
- Sponsor's protocol ID
- 328/15.05.2018
- Acronym
- QOLNAFLD
- Status last verified
- May 2022
- First submitted
- 17 May 2018
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Quality of Life in Patients With Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT03613480
- Acronym / sponsor ID
- QOLNAFLD / 328/15.05.2018
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital of PatrasUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All eligible patients will be randomized to receive either counseling sessions or care as usual
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing | Experimental | Other: Motivational InterviewingPatients 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. |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Non-alcoholic fatty liver disease according to the EASL-EASD-EASO Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingRegular sessions of Motivational Interviewing at 2 weeks and then at monthly intervals for a period of 6 months | Other | Motivational Interviewing |
Primary outcome
Health Survey 36 Short Form (SF36)
Time frame: 6 months
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.
Hospital Anxiety and Depression Scale (HADS)
Time frame: 6 months
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
Chronic Liver Disease Questionnaire (CLDQ)
Time frame: 6 months
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.
Fatigue Severity Scale
Time frame: 6 months
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
3 secondary outcomes
Alanine aminotransferase levels (ALT)
Time frame: 6 months
Aspartate aminotransferase levels (AST)
Time frame: 6 months
Body Mass Index (BMI)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing in people with Non-Alcoholic Fatty Liver Disease, run by University Hospital of Patras at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Survey 36 Short Form (SF36) (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.