UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057473 |
|---|---|
| Receipt number | R000065415 |
| Scientific Title | Early detection of covert hepatic encephalopathy and quality of life improvement in patients with chronic liver disease through the utilization of medical staff |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/03/28 21:04:46 |
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Basic information
Public title
Early detection of covert hepatic encephalopathy and quality of life improvement in patients with chronic liver disease through the utilization of medical staff
Acronym
Medical staff-based early detection of covert heptic encephalopathy and quality of life improvement
Scientific Title
Early detection of covert hepatic encephalopathy and quality of life improvement in patients with chronic liver disease through the utilization of medical staff
Scientific Title:Acronym
Medical staff-based early detection of covert heptic encephalopathy and quality of life improvement
Region
| Japan |
Condition
Condition
Chronic liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the impact of medical staff conducting simplified QOL assessments, evaluating covert hepatic encephalopathy, and providing information under the supervision of physicians on the QOL and covert hepatic encephalopathy of patients with chronic liver disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree of change in CLDQ scores after 6 months
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals who are 20 years old or older at the time of obtaining consent.
Individuals who have received a thorough explanation about participation in this study, fully understood it, and provided written consent of their own free will.
Key exclusion criteria
Individuals who are unable to complete the questionnaire.
Individuals who are considered unable to operate the app sufficiently (e.g., due to visual impairments, color blindness, etc.).
Individuals diagnosed with overt hepatic encephalopathy, such as those with tremors or clear consciousness disturbances.
Individuals diagnosed with other neurological diseases, such as dementia.
Individuals with motor function disabilities.
Any other individuals deemed unsuitable for participation by the principal investigator.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Nakai |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8648
Address
Kita 14,Nishi5,Kita-ku,Sapporo-shi,Hokkaido,Japan
TEL
+81-11-706-1161
mnakai@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Nakai |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8648
Address
Kita 14,Nishi5,Kita-ku,Sapporo-shi,Hokkaido,Japan
TEL
+81-11-706-1161
Homepage URL
mnakai@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita 14,Nishi5,Kita-ku,Sapporo-shi,Hokkaido,Japan
Tel
+81-11-706-7636
crjimu@huhp.hokudai.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 04 | Month | 01 | Day |
Last modified on
| 2025 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065415
