UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045285 |
|---|---|
| Receipt number | R000048654 |
| Scientific Title | Evaluation of sobriety-diary mobile application to assist abstinence in patients with alcohol-associated liver diseases |
| Date of disclosure of the study information | 2021/08/30 |
| Last modified on | 2024/09/18 08:00:08 |
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Basic information
Public title
Evaluation of sobriety-diary mobile application
to assist abstinence in patients with alcohol-associated liver diseases
Acronym
Sobriety-diary app in ALD patients
Scientific Title
Evaluation of sobriety-diary mobile application
to assist abstinence in patients with alcohol-associated liver diseases
Scientific Title:Acronym
Sobriety-diary app in ALD patients
Region
| Japan |
Condition
Condition
Alcohol-related liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To avaluate the efficacy on assisting abstinent
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Abstinent rate at 4 and 8 weeks after the use of mobile app.
Key secondary outcomes
Change in AUDIT score
Change in ARRS score
Change in QOL score
Changes in liver function test results, changes in %CDT level
Medications prescribed by psychiatrists (if any)
Keywords used in diary app.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Use of abstinent diary app
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
1) Outpatient or inpatient with alcoholic liver disease seen at the Department of Gastroenterology and Hepatology, KMU medical center.
2) patients >=20 years old
3) Patients who is a heavy alcohol user; habitual ethanol use > 60g/day for male and >30g/day for female for more tha 5 years
4) Patients who are required abstinence or reduce drinking by his/her physician
5) Patients agree to be adviced for abstinence
6) Patients who are fully informed about the study, and who entered to the study voluntary.
Key exclusion criteria
1) No intention to reduce or stop drinking
2) Non-compliant to clinic visit
3) Non-compliant to physician's advice on abstinence
4) Concomitant severe psychiatric disorder
5) Patient who has been diagnosed with dementia
6) Patient who has been abstinent for more than 1 year
7) Be ruled unfit to the study by investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Noriyo |
| Middle name | |
| Last name | Yamashiki |
Organization
Kansai Medical University Medical Center
Division name
Department of Gastroenterology and Hepatology
Zip code
570-8507
Address
Fumizono 10-15, Moriguchi, Osaka
TEL
06-6992-1001
yamashno@takii.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Noriyo |
| Middle name | |
| Last name | Yamashiki |
Organization
Kansai Medical University Medical Center
Division name
Department of Gastroenterology and Hepatology
Zip code
570-8507
Address
Fumizono 10-15, Moriguchi, Osaka
TEL
06-6992-1001
Homepage URL
yamashno@takii.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University Medical Center / Center for Ethical Review
Address
Fumizono 10-15, Moriguchi, Osaka
Tel
06-6992-1001
rinriirb@hirakata.kmu.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
関西医科大学総合医療センター、関西医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 27 | Day |
Last modified on
| 2024 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048654
