UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the Effectiveness of Support Tool for Advance Care Planning in Chronic HEART Failure
Title of the study (Brief title)	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	Yasuo Sugano
Organization	National Cerebral and Cardiovascular Center
Division name	Department of Cardiovasular Medicine
Address	5-7-1 Fujishirodai, Suita-shi, Osaka
TEL	06-6833-5012
Email	ysugano@ncvc.go.jp

Public contact
Name of contact person	Yasuo Sugano
Organization	National Cerebral and Cardiovascular Center
Division name	Department of Cardiovasular Medicine
Address	5-7-1 Fujishirodai, Suita-shi, Osaka
TEL	06-6833-5012
Homepage URL
Email	ysugano@ncvc.go.jp

Sponsor
Institute	National Cerebral and Cardiovascular Center
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 09 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034054