UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061909 |
|---|---|
| Receipt number | R000070840 |
| Scientific Title | A Randomized Controlled Trial of a Tele Nursing Supported Crisis Plan for Psychological Well-Being in Patients with Parkinson's Disease |
| Date of disclosure of the study information | 2026/06/15 |
| Last modified on | 2026/06/15 09:44:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Randomized Controlled Trial of a Tele Nursing Supported Crisis Plan for Psychological Well-Being in Patients with Parkinson's Disease
Acronym
A Randomized Controlled Trial of a Tele Nursing Supported Crisis Plan for Psychological Well-Being in Patients with Parkinson's Disease
Scientific Title
A Randomized Controlled Trial of a Tele Nursing Supported Crisis Plan for Psychological Well-Being in Patients with Parkinson's Disease
Scientific Title:Acronym
A Randomized Controlled Trial of a Tele Nursing Supported Crisis Plan for Psychological Well-Being in Patients with Parkinson's Disease
Region
| Japan |
Condition
Condition
Parkinson's Disease
Classification by specialty
| Psychiatry | Nursing | Not applicable |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This exploratory randomized controlled trial aims to evaluate the feasibility and preliminary effectiveness of a tele nursing supported crisis planning intervention for patients with Parkinson's disease and to provide data for the design of a future definitive trial.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quick Inventory of Depressive Symptomatology Japanese Version
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Tele nursing supported crisis planning + usual care
Interventions/Control_2
usual care
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with stable medical conditions who participate in online communication.
Key exclusion criteria
Patients with an unstable medical condition that precludes participation in online communication.
Patients with cognitive impairment that interferes with study participation.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Hashimoto |
Organization
IRYO SOUSEI UNIVERSITY
Division name
Fuclty of Grobal Nursing
Zip code
2770803
Address
1-3-4 Koaota, Kashiwa-shi, Chiba
TEL
04-7136-0007
tomomihahsimoto.nr.rwd.tkyu@ymail.ne.jp
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Hashimoto |
Organization
IRYO SOUSEI UNIVERSITY
Division name
Fuclty of Grobal Nursing
Zip code
2770803
Address
1-3-4 Koaota, Kashiwa-shi, Chiba
TEL
04-7136-0007
Homepage URL
tomomihahsimoto.nr.rwd.tkyu@ymail.ne.jp
Sponsor or person
Institute
IRYO SOUSEI UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRYO SOUSEI UNIVERSITY
Address
1-3-4 Koaota, Kashiwa-shi, Chiba
Tel
04-7136-0007
tomomihahsimoto.nr.rwd.tkyu@ymail.ne.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 | 06 | Month | 15 | 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
| 2025 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | 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
| 2026 | Year | 06 | Month | 15 | Day |
Last modified on
| 2026 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070840
