UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029805 |
|---|---|
| Receipt number | R000034054 |
| Scientific Title | Evaluation of the Effectiveness of Support Tool for Advance Care Planning in Chronic HEART Failure |
| Date of disclosure of the study information | 2017/11/02 |
| Last modified on | 2017/11/02 15:20:04 |
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Basic information
Public title
Evaluation of the Effectiveness of Support Tool for Advance Care Planning in Chronic HEART Failure
Acronym
ACP-HEART
Scientific Title
Evaluation of the Effectiveness of Support Tool for Advance Care Planning in Chronic HEART Failure
Scientific Title:Acronym
ACP-HEART
Region
| Japan |
Condition
Condition
Chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effectiveness of support tool for advance care planning in chronic heart failure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree of attainment of shared decision making between patients and the attending doctors
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Administration of support tool for advance care planning
Interventions/Control_2
Control
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Age: 20 years or more
2) Stage C or D chronic heart failure
3) Admitted to hospital due to heart failure exacerbation
4) Written informed consent obtained
Key exclusion criteria
1) Communication difficulty
2) Serious physical symptoms
3) Serious psychological symptoms
4) Registered in heart transplant network
5) Difficulty in understanding explanation of the study
6) Enrollment in other clinical study
7) Inadequate for participating the study by any reason judged by the attending physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Sugano |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Cardiovasular Medicine
Zip code
Address
5-7-1 Fujishirodai, Suita-shi, Osaka
TEL
06-6833-5012
ysugano@ncvc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuo Sugano |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Cardiovasular Medicine
Zip code
Address
5-7-1 Fujishirodai, Suita-shi, Osaka
TEL
06-6833-5012
Homepage URL
ysugano@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research Association
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Women's Medical University Hospital
Kurume University Hospital
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
| 2017 | Year | 11 | Month | 02 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 09 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 02 | Day |
Last modified on
| 2017 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034054
