UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033304 |
|---|---|
| Receipt number | R000037967 |
| Scientific Title | Effect of rehospital intervention program on patients admitted to hospital due to exacerbation of heart failure |
| Date of disclosure of the study information | 2018/08/20 |
| Last modified on | 2021/07/15 08:48:56 |
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Basic information
Public title
Effect of rehospital intervention program on patients admitted to hospital due to exacerbation of heart failure
Acronym
Intervention study on rehospitalization for heart failure
Scientific Title
Effect of rehospital intervention program on patients admitted to hospital due to exacerbation of heart failure
Scientific Title:Acronym
Intervention study on rehospitalization for heart failure
Region
| Japan |
Condition
Condition
Chronic heart failure
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
and implementing the intervention program at the institution to which the certufied nurse specialist and certified nurse belongs reduces the rehospitalization rate and as a side effect It is aimed to verify the self-management ability of the patient.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Re-hospitalization rate before and after intervention
Key secondary outcomes
Patient self-management ability
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Regular heart failure education
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
Patients who were hospitalized with clinical scenario 2 body fluid excessive heart failure, patients with a hospitalization of heart failure more than 2 times
Key exclusion criteria
Patients who understand sentences and can not answer questions from outpatient medical treatment situations
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akemi Utsunomiya |
Organization
Kyoto University Graduate School
Division name
Graduate School of Medicine Department of Human Health Sciences
Zip code
Address
kawahara-chou35, shougoin, sakyouku, Kyoto-city
TEL
075-751-3933
u_akemi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akemi Utsunomiya |
Organization
Japan Association Cardiovascular Nursing
Division name
Policy Medical Compensation Committee
Zip code
Address
kawahara-chou35, shougoin, sakyouku, Kyoto-city
TEL
075-751-3933
Homepage URL
u_akemi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Japan Association Cardiovascular Nursing
Institute
Department
Personal name
Funding Source
Organization
Nursing system association. Social insurance coalition
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
Address
Tel
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
| 2018 | Year | 08 | Month | 20 | 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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2021 | 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 | 07 | Month | 06 | Day |
Last modified on
| 2021 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037967
