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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048573
Receipt No. R000055290
Scientific Title Implementation of Advance Care Planning by Care Managers. (Multi-institutional pre- and post-pilot comparative study)
Date of disclosure of the study information 2022/08/03
Last modified on 2022/08/03

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Basic information
Public title Implementation of Advance Care Planning by Care Managers.
(Multi-institutional pre- and post-pilot comparative study)
Acronym CMACP-PPP study
Scientific Title Implementation of Advance Care Planning by Care Managers.
(Multi-institutional pre- and post-pilot comparative study)
Scientific Title:Acronym CMACP-PPP study
Region
Japan

Condition
Condition Independence
Requiring help
Long-term care
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to estimate the improvement in ACP engagement of care service users before and after trained care managers implement ACP interventions with care service users.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ACP engagement after 6-12 weeks of intervention
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 ACP communication within 60 minutes per session
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Users who are assigned to a care manager
2. Users who are 65 years of age or older
3. Users who are able to have a communication about ACP.
4. Users who have family members who can discuss ACP with them.
5. Users who have a medical provider who can discuss ACP with them.
Key exclusion criteria 1. Users previously conducting ACP
2. Users whose care manager judged that they are mentally unstable and that ACP intervention or questionnaire survey would be undesirable.
3. Users whose physical condition has not been settled and for whom ACP is not desirable.
4. Users who are estimated to be under 12 weeks of care manager's intervention.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Mitsunori
Middle name
Last name Nishikawa
Organization National Center for Geriatrics and Gerontology
Division name Department of Palliative Care
Zip code 474-8511
Address 7-430 Morioka-cho, Obu City, Aichi
TEL 0562-46-2311
Email m4nishikawa@yahoo.co.jp

Public contact
Name of contact person
1st name Mitsunori
Middle name
Last name Nishikawa
Organization National Center for Geriatrics and Gerontology
Division name Department of Palliative Care
Zip code 474-8511
Address 7-430 Morioka-cho, Obu City, Aichi
TEL 0562-46-2311
Homepage URL
Email m4nishikawa@yahoo.co.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization National Center for Geriatrics and Gerontology
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 National Center for Geriatrics and Gerontology
Address 7-430 Morioka-cho, Obu City, Aichi
Tel 0562-46-2311
Email yaday@ncgg.go.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
2022 Year 08 Month 03 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
2022 Year 08 Month 02 Day
Date of IRB
2022 Year 08 Month 02 Day
Anticipated trial start date
2022 Year 09 Month 01 Day
Last follow-up date
2023 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 08 Month 03 Day
Last modified on
2022 Year 08 Month 03 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055290

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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