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Recruiting Observational

The Liver Cirrhosis Cognitive Decline Scale (LiCCoS)

NCT07418008 · tracked via the Priya Life Science India tracker
Phase
Observational
Started
2025-12-15
Last updated
2026-02-18

Condition(s) studied

Liver CirrhosisCognitive DysfunctionHepatic EncephalopathyNeurocognitive Disorders

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Psychometric validity and reliability of the Liver Cirrhosis Cognitive Decline Scale (LiCCoS) — Single assessment at enrollment (Day 1)
    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.

Trial sites (1)

FacilityCityRegionStatus
Maharishi Markandeshwar (Deemed to be University) Ambāla Haryana Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07418008 on ClinicalTrials.gov ↗ ← All trials in India