Electronic PHES vs Paper-based PHES for Hepatic Encephalopathy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe First Affiliated Hospital with Nanjing Medical University
About this trial
This is a prospective, multicenter, randomized crossover diagnostic accuracy study. A total of 80 patients with liver cirrhosis will be enrolled and randomly assigned to two sequence groups at a 1:1 ratio. Participants in Sequence A will complete the paper-based Psychometric Hepatic Encephalopathy Score (PHES) on Day 1 and the electronic PHES on Day 2; participants in Sequence B will receive the tests in reverse order. All tests will be performed at the same time of day with a 1-day washout interval to minimize carryover effect. The primary objective is to verify the equivalence of total scores between electronic and paper-based PHES. Secondary objectives include evaluating the consistency of MHE classification and individual subtest scores, and analyzing the effects of test sequence and time period on results. This study aims to provide evidence for clinical promotion of the electronic PHES tool.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 18 to 75 years
Confirmed diagnosis of liver cirrhosis based on clinical, laboratory, imaging, or liver biopsy evidence
Intact cognitive function, no overt hepatic encephalopathy (West-Haven grade ≥ II), and able to cooperate with neuropsychological tests
Voluntarily signed written informed consent with good compliance and full understanding of the study
Disqualifiers
Concomitant uncontrolled neuropsychiatric diseases affecting cognitive function (e.g., Alzheimer's disease, Parkinson's disease, post-stroke sequelae, severe depression/anxiety, schizophrenia)
Use of hypnotics, sedatives, or psychotropic drugs within the past 1 month
Severe alcohol dependence or substance abuse, unable to maintain abstinence
Current use of lactulose at screening
Trial design
Design model
Crossover
Treatments tested in this trial
Paper-based Psychometric Hepatic Encephalopathy Score (PHES)
Diagnostic testStandard paper-and-pencil version of PHES, including 5 subtests (NCT-A, NCT-B, DST, LTT, SDT), administered by trained investigators according to standard protocol.
Electronic Psychometric Hepatic Encephalopathy Score (PHES)
Diagnostic testElectronic mini-program version of PHES with identical subtests and scoring criteria as the paper version, administered on a tablet or smartphone.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Group A (Paper-then-Electronic Sequence)Other 2 interventions
Group B: Group B (Electronic-then-Paper Sequence)Other 2 interventions
Trial outcomes
Primary outcomes
1
Mean difference in total PHES score (electronic version minus paper version)
Paired difference of total PHES score between electronic and paper-based versions within the same participant. Equivalence will be verified by the two one-sided t-test (TOST), with the equivalence margin defined as -1 to +1 points. Equivalence is concluded if the 90% confidence interval of the mean difference falls entirely within the margin.
Time frame
Day 1, Day 2Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: