UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039576
Receipt number R000044920
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)
Date of disclosure of the study information 2020/03/01
Last modified on 2022/04/12 10:07:32

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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 or person

Institute

Osaka City General Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044920


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name