The Liver Cirrhosis Cognitive Decline Scale (LiCCoS)

NCT07418008 | Recruiting

• 1 other identifier: IEC3572
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

Brief 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. 1.Can the LiCCoS questionnaire reliably measure cognitive difficulties in adults with liver cirrhosis?
2. 2.Does the questionnaire correctly reflect differences in cognitive function across levels of liver disease severity?
3. 3.Do LiCCoS scores relate to results from commonly used cognitive screening tests?

Conditions

Liver Cirrhosis; Cognitive Dysfunction; Hepatic Encephalopathy; Neurocognitive Disorders

Keywords

LiCCoS; Liver cirrhosis; Cognitive impairment; Cognitive dysfunction; Hepatic encephalopathy; Patient-reported outcome measure; Psychometric validation; Scale development; Cognitive assessment; Chronic liver disease

Outcome Measures

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.

  Single assessment at enrollment (Day 1)

Secondary Outcomes (2)

• Convergent validity of LiCCoS with established cognitive screening tests

  Single assessment at enrollment (Day 1)

• Known-groups validity of LiCCoS across liver disease severity and demographic subgroups

  Single assessment at enrollment (Day 1)

Study Arms (1)

Adults with Liver Cirrhosis

Adults aged 18 to 75 years with a clinically confirmed diagnosis of liver cirrhosis who are enrolled to complete the Liver Cirrhosis Cognitive Decline Scale (LiCCoS) and related cognitive assessments as part of an observational, cross-sectional study. No intervention or change in medical care is involved

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaya: lead
• Maharishi Markendeswar University (Deemed to be University): collaborator

Study Sites (1)

Maharishi Markandeshwar (Deemed to be University)

Ambāla, Haryana, 133207, India

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis; Cognitive Dysfunction; Hepatic Encephalopathy; Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Mental Disorders; Liver Failure; Hepatic Insufficiency; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Rajat Rana, PhD

CONTACT

601127873697; rajatrana91@gmail.com

Plaban Nag, Pharm.D

CONTACT

916909952755; plabannag@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 18, 2026
• Study Start: December 15, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)