UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060878 |
|---|---|
| Receipt number | R000069664 |
| Scientific Title | The Association Between Advance Care Planning Readiness and Disease Progression, Loneliness, and Life Space Mobility in Parkinson's Disease Patients |
| Date of disclosure of the study information | 2026/03/09 |
| Last modified on | 2026/03/09 21:15:33 |
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Basic information
Public title
The Association Between Advance Care Planning Readiness and Disease Progression, Loneliness, and Life Space Mobility in Parkinson's Disease Patients
Acronym
PD-ACP
Scientific Title
The Association Between Advance Care Planning Readiness and Disease Progression, Loneliness, and Life Space Mobility in Parkinson's Disease Patients
Scientific Title:Acronym
PD-ACP
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Readiness for Advance Care Planning Scale is a recently developed instrument in Japan to assess preparedness for advance care planning. Although this scale has been used in studies involving cancer patients, chronic disease populations, and older adults, its applicability in patients with neurodegenerative diseases has not been fully investigated. Parkinson's disease is a chronic progressive disorder that often leads to gradual decline in physical and cognitive function, making timely advance care planning important. The aim of this study is to evaluate the applicability of the RACP Scale in patients with Parkinson's disease and to examine its associations with disease severity, loneliness, life space mobility, and quality of life. The findings may help clarify psychological readiness for advance care planning in Parkinson's disease and support earlier introduction of ACP in clinical practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
RACP scale
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
| 40 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 40 years
Diagnosed with Parkinson's disease according to the Movement Disorder Society clinical diagnostic criteria
Receiving treatment at participating hospitals
Provided written informed consent
Key exclusion criteria
Severe cognitive impairment or psychiatric disease that interferes with informed consent
Acute illness unrelated to Parkinson's disease
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | none |
| Last name | Hisahara |
Organization
Sapporo medical university
Division name
department of neurology
Zip code
060-8543
Address
291, Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
takumi1994@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | none |
| Last name | Funakoshi |
Organization
Sapporo medical university
Division name
Department of neurology
Zip code
060-8543
Address
291, Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
Homepage URL
takumi1994@sapmed.ac.jp
Sponsor or person
Institute
Sapporo medical university
Institute
Department
Personal name
Funding Source
Organization
Sapporo medical 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
Institutional Review Board of Sapporo Medical University Hospital
Address
291, Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo, Hokkaido, Japan
Tel
011-611-2111
ji-rskk@sapmed.ac.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
| 2026 | Year | 03 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2028 | Year | 01 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2026 | Year | 03 | Month | 09 | Day |
Last modified on
| 2026 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069664
