UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056922 |
|---|---|
| Receipt number | R000065049 |
| Scientific Title | The pilot study on robot intervention for elderly patients with psychiatric and neurodegenerative diseases, including dementia |
| Date of disclosure of the study information | 2025/02/04 |
| Last modified on | 2025/02/03 20:21:23 |
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Basic information
Public title
The pilot study to verify the usefulness of communication robots for elderly patients with psychiatric and neurodegenerative diseases, including dementia
Acronym
ROBOTEP study
Scientific Title
The pilot study on robot intervention for elderly patients with psychiatric and neurodegenerative diseases, including dementia
Scientific Title:Acronym
ROBOTEP study
Region
| Japan |
Condition
Condition
Mild cognitive impairment, dementia, depression, Parkinson's disease
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to conduct preliminary research to verify the effectiveness of using a communication robot in reducing psychiatric symptoms in elderly hospitalized patients with mild cognitive impairment, dementia, depression, and Parkinson's disease. We also consider ways to provide programs that can be implemented in hospital wards and where robots can easily demonstrate their effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Anxiety after 1 week of use
Key secondary outcomes
Depression and satisfaction with the application after 1 week of use
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The intervention group will be provided with a communication robot for one week (once a day, for 30 minutes each, for five weekdays) during inpatient treatment for the underlying disease.
Interventions/Control_2
The control group will not be provided with a communication robot and will only receive inpatient treatment for the underlying disease.
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
The selection criteria include patients hospitalized with a diagnosis of mild cognitive impairment, dementia, depression, or Parkinson's disease.
Key exclusion criteria
Patients with moderate or higher dementia (2 or more on the CDR), severe depression (19 or more on the HAM-D), or inability to take fall prevention actions will be excluded.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshie |
| Middle name | |
| Last name | Omachi |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Forensic Psychiatry
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL
042-341-2711
yomachi@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Yoshie |
| Middle name | |
| Last name | Omachi |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Forensic Psychiatry
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL
042-341-2711
Homepage URL
yomachi@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
National Center of Neurology and Psychiatry
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
Ethics Committee, National Center of Neurology and Psychiatry
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
Tel
042-341-2711
rinri-jimu@ncnp.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
国立精神・神経医療研究センター病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 04 | 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
| 2023 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 02 | Month | 03 | Day |
Last modified on
| 2025 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065049
