UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044734
Receipt number R000051078
Scientific Title A Prospective study to Examine feAsibility and effeCtiveness of hEart Failure clinic nUrse-Led Advance Care Planning
Date of disclosure of the study information 2021/07/01
Last modified on 2022/05/08 06:51:44

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Basic information

Public title

A study to examine feasibility and effectiveness of clinic-based Advance Care Planning for Heart Failure

Acronym

A study to examine feasibility and effectiveness of clinic-based ACP for HF

Scientific Title

A Prospective study to Examine feAsibility and effeCtiveness of hEart Failure clinic nUrse-Led Advance Care Planning

Scientific Title:Acronym

PEACEFUL-ACP

Region

Japan


Condition

Condition

Heart Failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine feasibility of clinic nurse-led ACP for HF and its effectiveness regarding process, behavior, and quality of care.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Change in the score of the Kansas City Cardiomyopathy Questionnaire between baseline and 6months after introduction of ACP

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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients who fulfill all the conditions below are eligible.
1) adult patients who regularly go to cardiology clinic in the Chiba University Hospital.
2) left ventricular ejection fraction below 40% despite guideline-directed optimal therapy.
3)mildly reduced left ventricular ejection fraction with unstable comorbidities.
4)patients in the transition phase from Stage C to D, or in Stage C and are interested in the disease trajectory.
5)consent to the continued ACP conversation with clinic nurses and doctors.
6)native or near-native of Japanese.

Key exclusion criteria

Patients who fulfill any of the conditions below are ineligible.
1) in Stage D and near end of life
2) unable to regularly come to the clinic
3) clinically significant dementia
4) life-limiting comorbidities with presumed prognosis within a year
5) reject to the study
6) decided as inappropriate by the investigators for other reasons

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Sho
Middle name
Last name Okada

Organization

Chiba University Hospital

Division name

Department of Cardiology

Zip code

260-8670

Address

1-8-1 Inohana Chuo-ku, Chiba

TEL

043-222-7171

Email

shookada-circ@umin.ac.jp


Public contact

Name of contact person

1st name Sho
Middle name
Last name Okada

Organization

Chiba University Hospital

Division name

Department of Cardiology

Zip code

260-8670

Address

1-8-1 Inohana Chuo-ku, Chiba

TEL

043-222-7171

Homepage URL


Email

shookada-circ@umin.ac.jp


Sponsor or person

Institute

Chiba University

Institute

Department

Personal name



Funding Source

Organization

Chiba University

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

Chiba University Graduate School of Medicine

Address

1-8-1 Inohana, Chuo-ku, Chiba

Tel

043-222-7171

Email

inohana-rinri@chiba-u.jp


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

2021 Year 07 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

Enrolling by invitation

Date of protocol fixation

2021 Year 06 Month 24 Day

Date of IRB

2021 Year 06 Month 23 Day

Anticipated trial start date

2021 Year 07 Month 02 Day

Last follow-up date

2023 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Items
1)Patient information
2)ACP related workload: proceeding, time, frequency, number of health care providers involved in ACP, etc
3)Patient reported outcomes: SF-12, KCCQ, MacNew, SDM-Q-9, HADS, NAS-J-HF
4)Safety of ACP
5)Tests: blood, urine
6)Specific tests: Pulse wave velocity, exercise tolerance, chest x ray, ECG, UCG
7)Medication


Management information

Registered date

2021 Year 07 Month 01 Day

Last modified on

2022 Year 05 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051078


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name