An interventional study of Paper-based PHES and Electronic PHES in Liver Cirrhosis, Hepatic Encephalopathy (HE) and Minimal Hepatic Encephalopathy, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Not applicable, Interventional, and Diagnostic
The goal of this clinical trial is to learn if an electronic version of the Psychometric Hepatic Encephalopathy Score (PHES) works as well as the standard paper version to diagnose minimal hepatic encephalopathy (MHE) in adults with liver cirrhosis. The main questions it aims to answer are:
Do the total scores of the electronic and paper tests match for the same patient? Do both tests classify patients as having MHE or not in the same way? Researchers will compare the electronic PHES to the paper PHES to see if they produce equivalent results.
Participants will:
Be assigned by chance to one of two groups. Group A will take the paper test first, then the electronic test the next day. Group B will take the electronic test first, then the paper test the next day.
Complete two cognitive tests (one paper-based and one electronic) on two separate days.
Provide information about their medical history and complete routine blood tests as part of their standard care.
Background: Hepatic encephalopathy (HE) is a common complication of liver cirrhosis. Minimal hepatic encephalopathy (MHE) often goes undiagnosed but is associated with an increased risk of overt HE and poorer survival. The Psychometric Hepatic Encephalopathy Score (PHES) is the recommended tool for MHE screening. However, the paper-based PHES is time-consuming, requires trained personnel, and is prone to data recording errors, limiting its widespread use. We developed an electronic PHES application with identical test contents to address these limitations.
Objective: This study aims to evaluate the equivalence of the electronic PHES compared to the paper-based PHES in patients with liver cirrhosis. The secondary objectives include comparing the consistency of MHE classification, subtest scores, and analyzing the effects of test time and sequence.
Methods: This is a prospective, multicenter, randomized crossover trial. A total of 80 patients with cirrhosis will be enrolled. Patients will be randomly assigned 1:1 to Group A (paper-based PHES on Day 1, electronic PHES on Day 2) or Group B (electronic PHES on Day 1, paper-based PHES on Day 2), with tests conducted at the same time of day.
Outcomes: The primary outcome is the intra-individual difference in total PHES scores (electronic minus paper-based). The equivalence margin is set at -1 to +1 points, evaluated using the two one-sided t-test (TOST) with a 90% confidence interval. Secondary outcomes include the Kappa coefficient for MHE classification consistency, the intraclass correlation coefficient (ICC) for subtest consistency, and a linear mixed-effects model to analyze sequence and period effects.
Analysis: Statistical analysis will be performed using SPSS 26.0 and GraphPad Prism 9. Continuous variables will be presented as mean ± standard deviation or median (interquartile range). Categorical variables will be presented as frequencies (percentages). P \< 0.05 will be considered statistically significant.
1,668 studies on the registry are indexed under Liver Cirrhosis; 360 are open to participants now.
This study's planned enrollment of 80 is above the median of 72 across 1,003 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 248 studies on the registry; 146 are open to participants now.
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Age between 18 and 75 years. Diagnosed with liver cirrhosis (based on clinical, laboratory, imaging, or liver biopsy).
Good cognition, no overt hepatic encephalopathy (OHE, West-Haven grade ≥ II), and able to cooperate with neuropsychological tests.
Voluntary signing of informed consent, good compliance, and fully understanding this clinical study.
Exclusion Criteria:
Uncontrolled neuropsychiatric disorders affecting cognitive function (e.g., Alzheimer's disease, Parkinson's disease, stroke sequelae, severe depression/anxiety, schizophrenia, etc.).
Use of hypnotics, sedatives, or psychotropic drugs within the past month. Severe alcohol dependence or drug abuse history, unable to cooperate with alcohol withdrawal or drug cessation.
Use of lactulose at screening.
Participants in Group A will take the paper-based PHES on Day 1, followed by the electronic PHES on Day 2.
Diagnostic Test: Paper-based PHES · Diagnostic Test: Electronic PHES
Participants in Group B will take the electronic PHES on Day 1, followed by the paper-based PHES on Day 2.
Diagnostic Test: Paper-based PHES · Diagnostic Test: Electronic PHES
The paper-based PHES is a standard, validated neuropsychological test administered using paper forms and a pen. It consists of five subtests: Number Connection Test A, Number Connection Test B, Digit Symbol Test, Line-Tracing Test, and Serial Dotting Test. Participants complete the test under the supervision of a trained researcher. The researcher records the completion time and error rates for each subtest, and the total PHES score is calculated manually according to standard guidelines.
The electronic PHES is a digital version of the standard PHES administered via a mobile application on a tablet or smartphone. The test content, subtest settings, and scoring criteria are identical to the paper-based version. The application automatically records completion times, errors, and calculates the total score. Researchers provide operational instructions and supervise the participants throughout the test.
Intra-individual Difference in Total PHES Scores (Electronic minus Paper-based)
The primary outcome is the intra-individual difference in total PHES scores between the electronic and paper-based tests. The equivalence margin is set at -1 to +1 points, evaluated using the Two One-Sided Tests (TOST) with a 90% confidence interval.
Time frame: Upon completion of testing on Day 1 and Day 2
Consistency of MHE Classification
Agreement in the classification of Minimal Hepatic Encephalopathy (MHE) between the electronic and paper-based PHES, analyzed using Kappa statistics.
Time frame: Upon completion of testing on Day 1 and Day 2
Consistency of Subtest Scores
Agreement of scores across the five subtests (NCT-A, NCT-B, DST, LTT, SDT) between the electronic and paper-based PHES, analyzed using Intraclass Correlation Coefficient (ICC).
Time frame: Upon completion of testing on Day 1 and Day 2
Effect of Test Sequence and Time Period
Analysis of the effects of test sequence and period on PHES scores using linear mixed-effects models.
Time frame: Upon completion of testing on Day 1 and Day 2
No study locations are listed for this record.
Plan to share: No
Start is estimated for Oct 2026; primary completion for Nov 2026, 1 month later.
Of 243 non-industry interventional studies with no phase under Liver Cirrhosis, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 73. This study's planned 1 month is below that.
Counting every sponsor, half of 253 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School →