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
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
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
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
