Development and Psychometric Validation of The Liver Cirrhosis Cognitive Decline Scale (LiCCoS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Psychometric validity and reliability of the Liver Cirrhosis Cognitive Decline Scale (LiCCoS)
研究概览
简要总结
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:
- Can the LiCCoS questionnaire reliably measure cognitive difficulties in adults with liver cirrhosis?
- Does the questionnaire correctly reflect differences in cognitive function across levels of liver disease severity?
- 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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
结局指标
主要结局
Psychometric validity and reliability of the Liver Cirrhosis Cognitive Decline Scale (LiCCoS)
时间窗: 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.
次要结局
- 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))
研究者
Dr. Rajat Rana
Researcher
University of Malaya