UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056378 |
|---|---|
| Receipt number | R000063044 |
| Scientific Title | Evaluation of the Implementation Effectiveness on Advance Care Planning by Physical Therapists and Occupational Therapists Using the End-of-Life Preference List Game as a Support Tool. (A single-center, pre- and post-pilot comparative study). |
| Date of disclosure of the study information | 2024/12/06 |
| Last modified on | 2025/05/19 18:24:52 |
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Basic information
Public title
Evaluation of the Implementation Effectiveness on Advance Care Planning by Physical Therapists and Occupational Therapists Using the End-of-Life Preference List Game as a Support Tool.
(A single-center, pre- and post-pilot comparative study).
Acronym
PTOTACP-PPP Study
Scientific Title
Evaluation of the Implementation Effectiveness on Advance Care Planning by Physical Therapists and Occupational Therapists Using the End-of-Life Preference List Game as a Support Tool.
(A single-center, pre- and post-pilot comparative study).
Scientific Title:Acronym
PTOTACP-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 a game-based ACP intervention by trained physical and occupational therapists 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 using end-of-life preference list game as a support tool
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 in the charge of physical therapists and occupational therapists
2. Users who are 65 years old or older
3. Users who are able to talk about ACP.
4. Users who have family members who can discuss ACP with them.
5. Users who have a health care provider who can discuss ACP with them.
Key exclusion criteria
1. Users who have been receiving ACP in the past.
2. Users who the physical therapist/occupational therapist determines to be mentally unstable and undesirable for ACP intervention or questionnaire survey.
3. Users whose physical condition is unstable and for whom ACP is not recommended.
4. Users who are expected to be involved with the physical therapist/occupational therapist for less than 3 months (12 weeks).
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
| 2024 | Year | 12 | Month | 06 | 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
| 2024 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 06 | Day |
Last modified on
| 2025 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063044
