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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035113
Receipt No. R000039992
Official scientific title of the study Research of usability using ICT system for home management in the patients with chronic disease
Date of disclosure of the study information 2018/12/03
Last modified on 2018/12/03

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Basic information
Official scientific title of the study Research of usability using ICT system for home management in the patients with chronic disease
Title of the study (Brief title) Usability of ICT system
Region
Japan

Condition
Condition Chronic heart failure, diabetes mellitus, chronic renal failure, chronic obstructive pulmonary disease
Classification by specialty
Medicine in general Cardiology Pneumology
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the utilization and the usability of ICT system
Basic objectives2 Others
Basic objectives -Others Usability
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Utilization and usability under of the system in clinical use condition
Key secondary outcomes Functional problems of the system

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 Patient who needs weight management
Patient who can measure the body weight
Obtained informed consent
Key exclusion criteria Patients who have serious underlying disease such as malignant tumor
Target sample size 50

Research contact person
Name of lead principal investigator Keizo Sato
Organization Kyushu University of Health and Welfare
Division name Department of Clinical Biochemistry
Address 1714-1, Yoshino-cho, Nobeoka-shi, Miyazaki-ken 882-8508, Japan
TEL 0982-23-5558
Email rinseikuhw@gmail.com

Public contact
Name of contact person Satomi Akazaki
Organization Kyushu Graduate School of Health and Welfare
Division name Department of Clinical Biochemistry
Address 1714-1, Yoshino-cho, Nobeoka-shi, Miyazaki-ken 882-8508, Japan
TEL 0982-23-5558
Homepage URL
Email rinseikuhw@gmail.com

Sponsor
Institute Kyushu University of Health and Welfare
Institute
Department

Funding Source
Organization Asahi Kasei Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 12 Month 03 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 03 Month 05 Day
Anticipated trial start date
2018 Year 12 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Study desgin:multicenter prospective observational study

Management information
Registered date
2018 Year 12 Month 03 Day
Last modified on
2018 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039992

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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