UMIN-CTR Clinical Trial

Basic information
Public title	Can heart failure clinical path for regional cooperation of Osaka Stops HEart Failure (OSHEF) avoid readmission for heart failure? "Characteristics of avoidant/non-avoidant cases"
Acronym	Can heart failure clinical path for regional cooperation avoid readmission for heart failure? "Characteristics of avoidant/non-avoidant cases"
Scientific Title	Avoidant rate of readmission for heart failure and characteristics of avoidant/non-avoidant cases introduced a heart failure clinical path for regional cooperation of Osaka Stops HEart Failure (OSHEF)
Scientific Title:Acronym	Avoidant rate of readmission for heart failure and characteristics of avoidant/non-avoidant cases introduced a heart failure clinical path for regional cooperation
Region	Japan

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

Objectives
Narrative objectives1	To investigate the characteristics of patients re-hospitalized by collecting patients' data including heart failure comprehension and compliance with self-management forms in heart failure patients who have introduced the heart failure regional cooperation path
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The clinical characteristics, understanding of heart failure, and compliance with self-management and heart failure points are compared between the readmission group and the non-readmission group.
Key secondary outcomes

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 have been given sufficient explanations to participate in this study, and with sufficient understanding, have given the written consent of the subject or the family
Key exclusion criteria	Patient judged by the investigator to be inappropriate as subject
Target sample size	350

Research contact person
Name of lead principal investigator	1st name Yukio Middle name Last name Abe
Organization	Osaka City General Hospital
Division name	Cardiology
Zip code	534-0021
Address	2-13-22, Miyakojimahondori, Miyakojima-ku, Osaka
TEL	06-6929-1221
Email	abeyukio@aol.com

Public contact
Name of contact person	1st name Yukio Middle name Last name Abe
Organization	Osaka City General Hospital
Division name	Cardiology
Zip code	534-0021
Address	2-13-22, Miyakojimahondori, Miyakojima-ku, Osaka
TEL	06-6929-1221
Homepage URL
Email	abeyukio@aol.com

Sponsor
Institute	Osaka City General Hospital
Institute
Department

Funding Source
Organization	Osaka City General 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	Osaka City General Hospital
Address	2-13-22, Miyakojimahondori, Miyakojima-ku, Osaka
Tel	06-6929-1221
Email	abeyukio@aol.com

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 03 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	No longer recruiting
Date of protocol fixation	2019 Year 10 Month 01 Day
Date of IRB	2019 Year 10 Month 01 Day
Anticipated trial start date	2020 Year 03 Month 01 Day
Last follow-up date	2023 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Grouping based on with/without readmission of heart failure. Investigating each group's level of understanding and adherence to the regional collaboration path for heart failure. In addition, clinical data such as blood tests and echocardiography are collected for each cases.

Management information
Registered date	2020 Year 02 Month 23 Day
Last modified on	2022 Year 04 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044920