Electronic PHES vs Paper-based PHES for Hepatic Encephalopathy

NCT07852416 — Not applicable, Not yet recruiting, 80 participants, The First Affiliated Hospital with Nanjing Medical University
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Evaluation of Diagnostic Performance of Electronic Psychometric Hepatic Encephalopathy Score (PHES): A Randomized Crossover Study

RegistryNCT07852416
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, crossover, masking: none, diagnostic
Enrollment80 (Estimated)
SponsorThe First Affiliated Hospital with Nanjing Medical University (Other)
ConditionsLiver Cirrhosis, Hepatic Encephalopathy, Minimal Hepatic Encephalopathy
InterventionsPaper-based Psychometric Hepatic Encephalopathy Score (PHES), Electronic Psychometric Hepatic Encephalopathy Score (PHES) (Diagnostic test)
Datesstart 2026-10-01 (estimated), primary completion 2027-09-01 (estimated), completion 2027-10-01 (estimated), first posted 2026-10-01, last updated 2026-10-01
Locations2 sites in China

Related Papers Related Patents Related Grants Related Experts
All trials for Liver Cirrhosis All trials for Hepatic Encephalopathy All trials of Paper-based Psychometric Hepatic Encephalopathy Score (PHES) All trials of Electronic Psychometric Hepatic Encephalopathy Score (PHES)

-Summary

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.

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+Detailed description

This is a randomized crossover diagnostic accuracy study. Each eligible participant will receive both the electronic PHES and paper-based PHES tests in a randomly assigned sequence, with a 1-day washout interval between the two tests.

+Arms and interventions

ArmTypeInterventionsDescription
Group A (Paper-then-Electronic Sequence)OtherDiagnostic Test: Paper-based Psychometric Hepatic Encephalopathy Score (PHES); Diagnostic Test: Electronic Psychometric Hepatic Encephalopathy Score (PHES)Participants receive paper-based PHES test on Day 1, and receive electronic PHES test on Day 2 with a 1-day washout interval between two tests.
Group B (Electronic-then-Paper Sequence)OtherDiagnostic Test: Paper-based Psychometric Hepatic Encephalopathy Score (PHES); Diagnostic Test: Electronic Psychometric Hepatic Encephalopathy Score (PHES)Participants receive electronic PHES test on Day 1, and receive paper-based PHES test on Day 2 with a 1-day washout interval between two tests.
  • Paper-based Psychometric Hepatic Encephalopathy Score (PHES) (Diagnostic test): Standard 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 test): Electronic mini-program version of PHES with identical subtests and scoring criteria as the paper version, administered on a tablet or smartphone.

+Outcome measures

Primary outcomes

  • Mean difference in total PHES score (electronic version minus paper version) [Day 1, Day 2]: 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.

+Eligibility

Sex: All, ages: 18 Years to 70 Years, accepts healthy volunteers

Inclusion Criteria:

1. Aged 18 to 75 years
2. Confirmed diagnosis of liver cirrhosis based on clinical, laboratory, imaging, or liver biopsy evidence
3. Intact cognitive function, no overt hepatic encephalopathy (West-Haven grade ≥ II), and able to cooperate with neuropsychological tests
4. Voluntarily signed written informed consent with good compliance and full understanding of the study

Exclusion Criteria:

1. Concomitant uncontrolled neuropsychiatric diseases affecting cognitive function (e.g., Alzheimer's disease, Parkinson's disease, post-stroke sequelae, severe depression/anxiety, schizophrenia)
2. Use of hypnotics, sedatives, or psychotropic drugs within the past 1 month
3. Severe alcohol dependence or substance abuse, unable to maintain abstinence
4. Current use of lactulose at screening

+Locations (2)

FacilityCityCountryStatus
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province People's Hospital)Nanjing, JiangsuChina
The Second Affiliated Hospital of Xi'an Jiaotong UniversityXi’an, ShanxiChina

+Study documents