Developing and testing the Liver Cirrhosis Cognitive Decline Scale (LiCCoS)
Official title: Development and Psychometric Validation of The Liver Cirrhosis Cognitive Decline Scale (LiCCoS)
Run by University of Malaya · NCT07418008 · Data updated 2026-11-12
This project will test a short questionnaire called LiCCoS to see if it can spot thinking and everyday mental problems in adults with liver cirrhosis.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 230 (estimated) |
| Sponsor | University of Malaya Academic / other |
| Locations | 1 site (Ambāla, Haryana) |
| Status | Recruiting |
| Started | December 15, 2025 |
| Main results expected | October 30, 2026 |
| Study ends | November 30, 2026 |
| Registry record updated | February 18, 2026 |
| Trial ID | NCT07418008 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 with a documented diagnosis of liver cirrhosis who can read the test language, are able to provide informed consent, and do not have overt Grade II+ hepatic encephalopathy are ideal candidates.
✕Probably not a fit
People with overt hepatic encephalopathy (Grade II or higher), major neurologic or psychiatric disorders, active substance use disorder, severe uncorrected sensory impairments, or severe systemic illness are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational, cross-sectional project aims to create and psychometrically validate a patient-reported instrument (LiCCoS) for cognitive difficulties linked to liver cirrhosis. Investigators will generate items grounded in attention, working memory, executive function, and psychomotor theory, then refine the questionnaire using responses from adults with clinically confirmed cirrhosis. Participants will complete the LiCCoS along with standard cognitive measures and clinical data to test reliability, validity, and item performance. The goal is a short, easy-to-use tool suitable for routine clinical and research settings.
Why it matters
Potential benefit: If successful, LiCCoS could make it easier for clinicians to detect everyday cognitive problems in people with cirrhosis and help guide safer, more personalized care.
How similar studies have gone: Objective cognitive batteries (e.g., PHES, EncephalApp) have been used in cirrhosis, but disease-specific patient-reported cognitive scales like LiCCoS are relatively novel and have limited prior validation.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Maharishi Markandeshwar (Deemed to be University)
Ambāla, Haryana, India Recruiting
Study contacts
- Study coordinator: Rajat Rana, PhD
- Email: rajatrana91@gmail.com
- Phone: 601127873697
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.