UMIN-CTR Clinical Trial

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
Institute	Chiba University
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051078