Developing and testing the Liver Cirrhosis Cognitive Decline Scale (LiCCoS)
Development and Psychometric Validation of The Liver Cirrhosis Cognitive Decline Scale (LiCCoS)
University of Malaya · NCT07418008
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 |
|---|---|
| Enrollment | 230 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Malaya (other) |
| Locations | 1 site (Ambāla, Haryana) |
| Trial ID | NCT07418008 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Ambāla, Haryana
- Maharishi Markandeshwar (Deemed to be University) — Ambāla, Haryana, India (RECRUITING)
Study contacts
- Study coordinator: Rajat Rana, PhD
- Email: rajatrana91@gmail.com
- Phone: 601127873697
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Liver Cirrhosis, Cognitive Dysfunction, Hepatic Encephalopathy, Neurocognitive Disorders, LiCCoS, Liver cirrhosis, Cognitive impairment, Cognitive dysfunction