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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034918
Receipt No. R000039797
Scientific Title The effect of patient education intervention in hospitalized patient with heart failure
Date of disclosure of the study information 2019/05/01
Last modified on 2019/06/08

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Basic information
Public title The effect of patient education intervention in hospitalized patient with heart failure
Acronym The effect of patient education intervention in hospitalized patient with heart failure
Scientific Title The effect of patient education intervention in hospitalized patient with heart failure
Scientific Title:Acronym The effect of patient education intervention in hospitalized patient with heart failure
Region
Japan

Condition
Condition Heart failure(HF)
Classification by specialty
Cardiology Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to assess the effectiveness of multidisciplinary patient education for patients hospitalized with heart failure preserved ejection fraction
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Proportion of HF-related hospital readmission
Key secondary outcomes The Japanese Heart Failure Knowledge Scale
The European heart failure self-care behavior scale
Proportion of daily dairy use
Health related QOL

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
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 Multidisciplinary patient education by using the teach-back method during the hospital stay
Interventions/Control_2 Usual care
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)patient hospitalized with heart failure
2)patient with heart failure preserved ejection fraction
Key exclusion criteria 1) Poor prognosis due to severe comorbidity
2) Be expected to discharge to non-home
3) Do not speak or read Japanese
4) Severe cognitive impairment and severe psychiatric condition
5) Patients who have participated in other studies
Target sample size 190

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name Kohzuki
Organization Tohoku University Graduate School of Medicine
Division name Department of Internal medicine and rehabilitation science
Zip code 980-8574
Address 1-1, Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan
TEL 022-717-7351
Email kohzuki@med.tohoku.ac.jp

Public contact
Name of contact person
1st name Shintaro
Middle name
Last name Togashi
Organization Tohoku University Graduate School of Medicine
Division name Department of Internal medicine and rehabilitation science
Zip code 980-8574
Address 1-1, Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan
TEL 022-717-7353
Homepage URL
Email shintaro.togashi42@med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Not receive funds
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Independent Ethics Committee, Tohoku University Graduate School of Medicine
Address 1-1, Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan
Tel 022-728-4105
Email med-kenkyo@grp.tohoku.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 一般財団法人厚生会 仙台厚生病院

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 01 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
2018 Year 12 Month 01 Day
Date of IRB
2019 Year 02 Month 12 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2022 Year 01 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
2018 Year 11 Month 17 Day
Last modified on
2019 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039797

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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