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
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
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
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
