The Liver Cirrhosis Cognitive Decline Scale (LiCCoS) (LiCCoS)

February 10, 2026 updated by: Dr. Rajat Rana, University of Malaya

Development and Psychometric Validation of The Liver Cirrhosis Cognitive Decline Scale (LiCCoS)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This study is an observational, cross-sectional investigation designed to develop and psychometrically validate a patient-reported outcome measure, the Liver Cirrhosis Cognitive Decline Scale (LiCCoS), for adults with clinically confirmed liver cirrhosis. The study focuses on cognitive difficulties associated with cirrhosis, including attention, psychomotor speed, working memory, executive function, and cirrhosis-related impacts on daily functioning.

Study Rationale and Conceptual Framework

Cognitive impairment related to liver cirrhosis is common and may occur even in the absence of overt hepatic encephalopathy. While several objective tests are used in clinical practice, these tools often require trained personnel or specialized administration and may not adequately reflect participant-perceived cognitive difficulties in everyday life. LiCCoS is intended to address this gap by providing a disease-specific, patient-reported instrument grounded in neurocognitive theory and clinical relevance to cirrhosis.

The conceptual framework for LiCCoS integrates established models of attention, working memory, executive function, and psychomotor processing, together with cirrhosis-specific functional impacts. Items are framed in participant-centered language to enhance interpretability and usability in routine clinical and research settings.

Study Design and Phases

The study will be conducted in multiple sequential phases:

Phase 1: Item Generation An initial pool of items will be generated using a structured literature review and semi-structured interviews with adults living with liver cirrhosis. This process aims to ensure comprehensive coverage of relevant cognitive domains and real-world functional concerns.

Phase 2: Content Validation A multidisciplinary expert panel, including clinicians and cognitive specialists, will evaluate item relevance and clarity. Content validity will be assessed using standard content validity indexing methods to guide item refinement.

Phase 3: Face Validity and Pilot Testing The refined questionnaire will be pilot-tested in a small group of participants to evaluate clarity, comprehension, and feasibility. Feedback from this phase will inform final adjustments before large-scale validation.

Phase 4: Psychometric Validation The finalized LiCCoS will be administered to a larger sample of adults with liver cirrhosis. Psychometric evaluation will include assessment of dimensionality, internal consistency reliability, and construct validity. Factor structure will be examined using exploratory and confirmatory approaches, and relationships with established cognitive screening tools and clinical severity classifications will be evaluated.

Data Collection and Study Procedures

Participants will complete LiCCoS once during a routine outpatient visit or through a secure data collection platform, depending on participant preference. Standard cognitive screening tools used in routine clinical care may also be administered for validation purposes. Sociodemographic and clinical information relevant to disease characterization will be collected from participants and verified through medical records when available.

No experimental intervention, treatment modification, or clinical decision-making is part of this study. All procedures are observational in nature.

Data Management and Quality Assurance

Data will be collected using structured case report forms or secure electronic data capture systems with restricted access. Quality assurance measures will include:

Predefined data entry rules to minimize missing or inconsistent responses

Range and logic checks to identify out-of-range or internally inconsistent data

Periodic review of collected data by the study team for completeness and accuracy

Secure storage of de-identified data using coded participant identifiers

Source data verification may be conducted on a subset of records by comparing collected data with medical records to assess accuracy and completeness.

A data dictionary will be maintained to define all variables, response options, and scoring rules used in the study. Standard operating procedures will guide participant recruitment, data collection, data handling, and analysis activities.

Sample Size Considerations

The planned sample size is based on methodological recommendations for scale development and psychometric validation, using participant-to-item ratios sufficient to support factor analysis and reliability assessment. The total sample will include participants enrolled during pilot testing and the main validation phase.

Statistical Analysis Overview

Statistical analyses will be conducted using standard statistical software. Descriptive statistics will summarize participant characteristics. Psychometric analyses will assess reliability, dimensionality, and construct validity of LiCCoS. Comparative analyses will explore score differences across clinically relevant subgroups defined by disease severity and demographic factors.

Ethical and Regulatory Considerations

The study will be conducted in accordance with the Declaration of Helsinki and applicable national and institutional ethical guidelines. Ethical approval will be obtained prior to participant enrollment. Written informed consent will be obtained from all participants before data collection. LiCCoS scores will not be used for diagnosis or treatment decisions and are intended solely for research validation purposes

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
230

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • India
    • Haryana
      • Ambāla, Haryana, India, 133207
        • Recruiting
        • Maharishi Markandeshwar (Deemed to be University)
        • Contact:
        • Sub-Investigator:
          • Plaban Nag, Pharm.D
        • Sub-Investigator:
          • Rajnandani Prajapat, Rajnandani
        • Sub-Investigator:
          • Shivani Billa, Pharm.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Psychometric validity and reliability of the Liver Cirrhosis Cognitive Decline Scale (LiCCoS)
Time Frame: 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.
Single assessment at enrollment (Day 1)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Convergent validity of LiCCoS with established cognitive screening tests
Time Frame: Single assessment at enrollment (Day 1)
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.
Single assessment at enrollment (Day 1)
Known-groups validity of LiCCoS across liver disease severity and demographic subgroups
Time Frame: Single assessment at enrollment (Day 1)
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.
Single assessment at enrollment (Day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Malaya

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Maharishi Markendeswar University (Deemed to be University)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IEC3572

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared. The data collected in this study are derived from a newly developed, institution-specific questionnaire and include sensitive health and cognitive information. Data sharing is restricted to protect participant privacy and confidentiality, in accordance with institutional ethics approval, informed consent provisions, and applicable data protection regulations. Only aggregated, de-identified results will be reported through publications and registry postings.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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