UMIN-CTR Clinical Trial

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
Email	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
Email	satoma-tky@umin.ac.jp

Sponsor
Institute	Department of Gastroenterology, The University of Tokyo
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026482