UMIN-CTR Clinical Trial

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	20
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	Completed
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	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 11 Month 17 Day
Last modified on	2020 Year 05 Month 20 Day

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