RecruitingNot Applicable

The Liver Cirrhosis Cognitive Decline Scale (LiCCoS)

India230 participantsStarted 2025-12-15

Plain-language summary

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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Known case of Any neurological and psychological disorders, substance use disorder and sleep disorders. * Known case of Severe systemic illness (e.g., end-stage renal disease, decompensated heart failure) that may independently impair cognition or limit participation.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Psychometric validity and reliability of the Liver Cirrhosis Cognitive Decline Scale (LiCCoS)

Timeframe: Single assessment at enrollment (Day 1)

Trial details

NCT IDNCT07418008

SponsorUniversity of Malaya

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-10-30

Contact for this trial

Rajat Rana, PhD

601127873697 rajatrana91@gmail.com

View on ClinicalTrials.gov More Liver Cirrhosis trials