[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658565":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":32,"overallOfficials":13,"centralContacts":42,"locations":48,"responsibleParty":74,"collaborators":13,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":13,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":13,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":13,"overallStatus":98,"whyStopped":13,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"The First Affiliated Hospital with Nanjing Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"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.","Day 1, Day 2",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","CROSSOVER","DIAGNOSTIC",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","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.",[22,28],{"label":23,"type":6,"description":24,"interventionNames":25},"Group A (Paper-then-Electronic Sequence)","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.",[26,27],"Diagnostic Test: Paper-based Psychometric Hepatic Encephalopathy Score (PHES)","Diagnostic Test: Electronic Psychometric Hepatic Encephalopathy Score (PHES)",{"label":29,"type":6,"description":30,"interventionNames":31},"Group B (Electronic-then-Paper Sequence)","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.",[26,27],[33,38],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":13},"DIAGNOSTIC_TEST","Paper-based Psychometric Hepatic Encephalopathy Score (PHES)","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.",[23,29],{"type":34,"name":39,"description":40,"armGroupLabels":41,"otherNames":13},"Electronic Psychometric Hepatic Encephalopathy Score (PHES)","Electronic mini-program version of PHES with identical subtests and scoring criteria as the paper version, administered on a tablet or smartphone.",[23,29],[43],{"name":44,"role":45,"phone":46,"phoneExt":13,"email":47},"Longfeng Jiang","CONTACT","+86 13701583756","longfengjiang@jnmu.edu.cn",[49,63],{"facility":50,"status":13,"city":51,"state":52,"zip":13,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province People's Hospital)","Nanjing","Jiangsu","China","CN",{"type":56,"coordinates":57},"Point",[58,59],118.77778,32.06167,{"lat":59,"lon":58},[62],{"name":44,"role":45,"phone":46,"phoneExt":13,"email":47},{"facility":64,"status":13,"city":65,"state":66,"zip":13,"country":53,"countryCode":54,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"The Second Affiliated Hospital of Xi'an Jiaotong University","Xi’an","Shanxi",{"type":56,"coordinates":68},[69,70],113.52486,35.99785,{"lat":70,"lon":69},[73],{"name":44,"role":45,"phone":46,"phoneExt":13,"email":47},{"type":75,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100658565","electronic-phes-vs-paper-based-phes-for-hepatic-encephalopathy-100658565",false,"NCT07852416","Electronic PHES vs Paper-based PHES for Hepatic Encephalopathy","Evaluation of Diagnostic Performance of Electronic Psychometric Hepatic Encephalopathy Score (PHES): A Randomized Crossover Study","Inclusion Criteria:\n\n1. Aged 18 to 75 years\n2. Confirmed diagnosis of liver cirrhosis based on clinical, laboratory, imaging, or liver biopsy evidence\n3. Intact cognitive function, no overt hepatic encephalopathy (West-Haven grade ≥ II), and able to cooperate with neuropsychological tests\n4. Voluntarily signed written informed consent with good compliance and full understanding of the study\n\nExclusion Criteria:\n\n1. Concomitant uncontrolled neuropsychiatric diseases affecting cognitive function (e.g., Alzheimer's disease, Parkinson's disease, post-stroke sequelae, severe depression\u002Fanxiety, schizophrenia)\n2. Use of hypnotics, sedatives, or psychotropic drugs within the past 1 month\n3. Severe alcohol dependence or substance abuse, unable to maintain abstinence\n4. Current use of lactulose at screening",true,"ALL","18 Years","70 Years",{"count":88,"type":89},80,"ESTIMATED","INTERVENTIONAL",[92],"NA","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.",[95,96,97],"Liver Cirrhosis","Hepatic Encephalopathy","Minimal Hepatic Encephalopathy","NOT_YET_RECRUITING","2026-09-30",{"date":101,"type":102},"2026-10-01","ACTUAL",{"date":101,"type":89},{"date":105,"type":89},"2027-10-01",{"name":5,"class":6},2]