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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028156
Receipt No. R000032195
Scientific Title Educational intervention of heart failure by using pocket computer tablet
Date of disclosure of the study information 2017/07/10
Last modified on 2019/07/17

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Basic information
Public title Educational intervention of heart failure
by using pocket computer tablet
Acronym Educational intervention of heart failure
by using pocket computer tablet
Scientific Title Educational intervention of heart failure
by using pocket computer tablet
Scientific Title:Acronym Educational intervention of heart failure
by using pocket computer tablet
Region
Japan

Condition
Condition heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the usefulness of educational approach by using the pocket computer tablet
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes changes in the european self behaviour scale before and after educational approach
Key secondary outcomes total time required for the educational intervention

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Educational intervention by using the pocket computer tablet
Interventions/Control_2 Educational intervention by using the
teaching paper pamphlet
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 hospitalized with heart failure
Key exclusion criteria dementia (MMSE below 21 points)
depression (PHQ-9 over 10 points)
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiharu Kinugasa
Organization Tottori University
Division name Division of Cardiovascular Medicine, Department of Molecular Medicine and Therapeutics, Faculty of Medicine,
Zip code
Address 36-1 Nishicho, Yonago 683-8504, Japan
TEL 0859-38-6517
Email ykinugasa-circ@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiharu Kinugasa
Organization Tottori University
Division name Division of Cardiovascular Medicine, Department of Molecular Medicine and Therapeutics, Faculty of
Zip code
Address 36-1 Nishicho, Yonago 683-8504, Japan
TEL 0859-38-6517
Homepage URL
Email ykinugasa-circ@umin.ac.jp

Sponsor
Institute Tottori university hospital
Institute
Department

Funding Source
Organization Tottori university hospital
Organization
Division
Category of Funding Organization Other
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 07 Month 10 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 Open public recruiting
Date of protocol fixation
2017 Year 02 Month 03 Day
Date of IRB
2017 Year 04 Month 01 Day
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
2019 Year 07 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 10 Day
Last modified on
2019 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032195

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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