UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048573 |
|---|---|
| Receipt number | 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 | 2024/02/19 12:28:55 |
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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
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
m4nishikawa@yahoo.co.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
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
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
Public access to protocols is difficult.
Publication of results
Unpublished
Result
URL related to results and publications
Paper is currently submitted and under peer review.
Number of participants that the trial has enrolled
30
Results
The ACP engagement score was 2.00 on average before ACP communication and 3.54 on average after ACP communication, a statistically significant improvement.
Results date posted
| 2024 | Year | 02 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Thirty long-term care service users (7 men and 23 women) participated in the study.
Participant flow
Thirty long-term care service users completed the study without dropping out.
Adverse events
No problematic adverse events were observed in 30 long-term care service users.
Outcome measures
The ACP engagement score was 2.00 on average before ACP communication and 3.54 on average after ACP communication, a statistically significant improvement.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
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 | 15 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 03 | Month | 26 | Day |
Date analysis concluded
| 2023 | Year | 07 | Month | 26 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 03 | Day |
Last modified on
| 2024 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
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 | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
