UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025912 |
|---|---|
| Receipt number | R000026482 |
| Scientific Title | Feasibility Study of Continuous Intervention with Designated Treatment Application for NASH (Non-Alcoholic Steatohepatitis) Patients |
| Date of disclosure of the study information | 2017/01/31 |
| Last modified on | 2021/07/27 19:12:15 |
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Basic information
Public title
Feasibility Study of Continuous Intervention with Designated Treatment Application for NASH (Non-Alcoholic Steatohepatitis) Patients
Acronym
Continuous Intervention of Application for NASH patients
Scientific Title
Feasibility Study of Continuous Intervention with Designated Treatment Application for NASH (Non-Alcoholic Steatohepatitis) Patients
Scientific Title:Acronym
Continuous Intervention of Application for NASH patients
Region
| Japan |
Condition
Condition
Non-Alcoholic Steatohepatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the use rate of aid and intervention application for patients with Non-Alcoholic Steatohepatitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The use or achievement rate of program provided by application
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention and aid application for improvement of non-alcoholic steatohepatitis
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients diagnosed as non-alcoholic steatohepatitis by clinical examinations including imageinspection and who agree to participate in the study after enough explanation about the study.
Key exclusion criteria
exclusion criteria
1. a patient does not agree
2. a patient who the attending physician think is does not seem able to use a smartphone.
3. pregnant patients.
4. patients with comorbid hepatitis (e.g., viral hepatitis, autoimmune hepatitis)
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryosuke Tateishi |
Organization
The University of Tokyo
Division name
Cancer Professional Training Plan, Department of Gastroenterology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku
TEL
+81-3-3815-5411
tateishi-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaya Sato |
Organization
The University of Tokyo
Division name
Department of Clinical Laboratory Medicine , Department of Gastroenterology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku
TEL
+81-3-3815-5411
Homepage URL
satoma-tky@umin.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
CureApp, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 01 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.longdom.org/open-access/effect-of-smartphone-applicationenabled-daily-intervention-for-p
Number of participants that the trial has enrolled
9
Results
Since one patient was lost to follow-up, the comparison between pre- and post-intervention values was performed for 8 patients. A post-intervention weight reduction was observed in 7 patients, and this weight reduction was statistically significant (p=0.02).Normalization of the ALT level (<30 U/L) was observed in two patients.
Results date posted
| 2021 | Year | 07 | Month | 19 | Day |
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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 30 | Day |
Last modified on
| 2021 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026482
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
