The Liver Cirrhosis Cognitive Decline Scale (LiCCoS)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorUniversity of Malaya
About this trial
The goal of this observational study is to develop and test a new questionnaire called the Liver Cirrhosis Cognitive Decline Scale (LiCCoS) for adults with liver cirrhosis. This questionnaire is designed to help identify problems with thinking and daily mental functioning that are common in people with liver cirrhosis but are often missed during routine care.
People with liver cirrhosis may experience problems such as forgetfulness, slowed thinking, trouble paying attention, or difficulty planning everyday tasks. These problems can affect daily life, safety, and treatment adherence. Existing cognitive tests often require special training or equipment and may not fully reflect how people experience these difficulties in daily life. This study aims to create a simple, patient-reported tool that captures these concerns in an easy and practical way.
The main questions this study aims to answer are:
1. Can the LiCCoS questionnaire reliably measure cognitive difficulties in adults with liver cirrhosis? 2. Does the questionnaire correctly reflect differences in cognitive function across levels of liver disease severity? 3. Do LiCCoS scores relate to results from commonly used cognitive screening tests?
Participants will be adults aged 18 to 75 years who have a confirmed diagnosis of liver cirrhosis and are attending outpatient clinics. Participation is voluntary.
Participants will:
Provide basic background information, such as age and medical history
Complete the LiCCoS questionnaire about their thinking and daily mental functioning
Complete standard cognitive screening tests commonly used in clinical care
This study does not involve any treatment or change in medical care. The information collected will be used only for research purposes. The results are expected to help develop a reliable and easy-to-use tool that can support early recognition of cognitive difficulties in people with liver cirrhosis and improve communication between participants and health care providers.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 years.
Documented clinical diagnosis of liver cirrhosis based on imaging, histology, or validated clinical criteria.
Able to read and understand the language of the cognitive tests.
Willing and able to provide written informed consent.
Disqualifiers
Age <18 or >75 years
Known case of Overt Hepatic Encephalopathy defined as Grade II or higher on the West Haven criteria [25].
Use of central nervous system depressants, anticholinergics, or psychotropics initiated or changed within the past 4 weeks.
Known case of Severe uncorrected visual or hearing impairment limiting ability to complete cognitive testing.
Trial population
Participants will be recruited from adults receiving outpatient care for liver cirrhosis at the Departments of Gastroenterology and General Medicine of Maharishi Markandeshwar Institute of Medical Sciences and Research (MMIMSR) Hospital, Mullana, Haryana, India. The study population represents individuals with clinically managed chronic liver disease who attend Maharishi Markandeshwar Super Specialty Hospital and are capable of completing questionnaire-based assessments. Recruitment will occur during regular clinic visits without altering standard medical care.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
230 Participants
are grouped into 1 trial groupGroup A: Adults with Liver Cirrhosis
Trial outcomes
Primary outcomes
1
Psychometric validity and reliability of the Liver Cirrhosis Cognitive Decline Scale (LiCCoS)
Assessment of the measurement properties of the Liver Cirrhosis Cognitive Decline Scale (LiCCoS), including content validity, internal consistency reliability, and factor structure. Psychometric performance will be evaluated using standard validation metrics to determine whether LiCCoS reliably measures cognitive difficulties in adults with liver cirrhosis.
Time frame
Single assessment at enrollment (Day 1)Secondary outcomes
1
Convergent validity of LiCCoS with established cognitive screening tests
Evaluation of the association between LiCCoS scores and scores from commonly used cognitive screening tools (e.g., Mini-Mental State Examination) to determine whether LiCCoS measures related cognitive constructs.
Time frame
Single assessment at enrollment (Day 1)2
Known-groups validity of LiCCoS across liver disease severity and demographic subgroups
Comparison of LiCCoS scores across predefined participant subgroups expected to differ in cognitive function, including liver disease severity (Child-Pugh classes A, B, and C), age groups, and cirrhosis etiology, to assess whether the scale can distinguish between clinically relevant groups.
Time frame
Single assessment at enrollment (Day 1)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Malaya
Lead sponsor
Maharishi Markendeswar University (Deemed to be University)
Collaborator
Source ClinicalTrials.gov