UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of personal health records in medical treatment support for patients with chronic diseases
Acronym	Effectiveness of personal health records
Scientific Title	Effectiveness of personal health records in medical treatment support for patients with chronic diseases
Scientific Title:Acronym	Effectiveness of personal health records in medical treatment support for patients with chronic diseases
Region	Japan

Condition
Condition	diabetes and chronic liver disease
Classification by specialty	Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1) Evalustion of the effect of PHR and FGM on the physiological data and patient-reported outcome of diabetes patients 2) Evaluation of the effect of PHR on the parthenogenesis of NASH patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Glycemic control of the patients with diabetes and body weight reduction of those with NASH
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	1. Inclusion - 3 month: patient uses PHR App and receives general medical care 2. 4-6 month: 1 and medical care by nurses using PHR data 3. 7-9 month: 1, 2 and medical care by nurses using message function of PHR 4. 10-18 month: general medical care. Use of PHR is up to the patients.
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	35 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	1. Patients with diabetes and/or NASH who are older than 20 y.o. 2. Diabetes patients who are treated with self-injection (insulin and GLP-1 agonist) and monitored their glucose level using FGM. 3. NASH patients are diagnosed by liver biopsy or imaging exam before inclusion.
Key exclusion criteria	1. Patients who cannot use PHR due to lack of understanding, visual impairment, cognitive impairment and movement disorder of the fingers. 2. Patients who are considered to be impropriety for the participation in this study by physician.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Keizo Middle name Last name Anzai
Organization	Faculty of Medicine, Saga University
Division name	Metabolism and Endocrinology
Zip code	849-8501
Address	5-1-1 Nabeshima,Saga
TEL	0952-31-6511
Email	akeizo@cc.saga-u.ac.jp

Public contact
Name of contact person	1st name Hirokazu Middle name Last name Takahashi
Organization	Faculty of Medicine, Saga University
Division name	Metabolism and Endocrinology
Zip code	849-8501
Address	5-1-1 Nabeshima,Saga
TEL	0952-31-6511
Homepage URL
Email	takahas2@cc.saga-u.ac.jp

Sponsor
Institute	Saga University
Institute
Department

Funding Source
Organization	Budget is covered by non-particular research funding of Division of Metabolism and Endocrinology, Saga University.
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	Clinical Research Center, Saga University Hospital
Address	5-1-1 Nabeshima,Saga
Tel	0952-34-3400
Email	clinstudycenter@mail.admin.saga-u.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	2020 Year 07 Month 15 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	2019 Year 12 Month 26 Day
Date of IRB	2020 Year 03 Month 02 Day
Anticipated trial start date	2020 Year 07 Month 15 Day
Last follow-up date	2022 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	2020 Year 07 Month 02 Day
Last modified on	2021 Year 07 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046765