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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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.

Locations
Other Locations
India
Maharishi Markandeshwar (Deemed to be University)
RECRUITING
Ambāla
Contact Information
Primary
Rajat Rana, PhD
rajatrana91@gmail.com
601127873697
Backup
Plaban Nag, Pharm.D
plabannag@gmail.com
916909952755
Time Frame
Start Date: 2025-12-15
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 230
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: University of Malaya
Collaborators: Maharishi Markendeswar University (Deemed to be University)

This content was sourced from clinicaltrials.gov