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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name