UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047304 |
|---|---|
| Receipt number | R000053947 |
| Scientific Title | The Impact of Different Psychiatric Day Care Programs on Outcomes. |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2022/03/28 20:01:08 |
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Basic information
Public title
The Impact of Different Psychiatric Day Care Programs on Outcomes.
Acronym
The Impact of Different Psychiatric Day Care Programs on Outcomes.
Scientific Title
The Impact of Different Psychiatric Day Care Programs on Outcomes.
Scientific Title:Acronym
The Impact of Different Psychiatric Day Care Programs on Outcomes.
Region
| Japan |
Condition
Condition
Mental disorder
Classification by specialty
| Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify whether the implementation of a frailty prevention program for day care users can be expected to improve their health compared to participation in a regular day care program alone.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brief Psychiatric Rating Scale Japanese Version
To be conducted before the start of the program and at the end of the program (after 12 weeks).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Conduct a frailty prevention program at a psychiatric day care once a week for about 30 minutes, 12 times, and measure outcomes before and after.
Interventions/Control_2
Participate in the regular program offered in psychiatric day care at least once a week for 12 sessions. Outcomes will be measured before and after the program.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who use day care at least once a week.
Those who are deemed by the physician to be able to participate in each program.
Key exclusion criteria
Those who are certified as requiring nursing care
Those who are unable to understand the content of the research
Those who are unable to voluntarily express their willingness to cooperate in the research.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | raimu |
| Middle name | |
| Last name | wakamatsu |
Organization
Tokyo Metropolitan University
Division name
Graduate School of Human Health Sciences, Department of Occupational Therapy Sciences, Pre-doctoral Program
Zip code
116-8551
Address
7-2-10, Higashiogu, Arakawa-ku, Tokyo, Japan
TEL
03-3819-1211
wakamatsu-raimu@ed.tmu.ac.jp
Public contact
Name of contact person
| 1st name | raimu |
| Middle name | |
| Last name | wakamatsu |
Organization
Tokyo Metropolitan University
Division name
Graduate School of Human Health Sciences, Department of Occupational Therapy Sciences, Pre-doctoral
Zip code
116-8551
Address
7-2-10, Higashiogu, Arakawa-ku, Tokyo, Japan
TEL
03-3819-1211
Homepage URL
wakamatsu-raimu@ed.tmu.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Tokyo Metropolitan University Arakawa Campus
Address
7-2-10, Higashiogu, Arakawa-ku, Tokyo, Japan
Tel
03-3819-1211
rinri-hs@tmu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
21086
Org. issuing International ID_1
Research Ethics Committee, Tokyo Metropolitan University Arakawa Campus
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 | 04 | Month | 01 | 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
| 2022 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 10 | 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
| 2022 | Year | 03 | Month | 28 | Day |
Last modified on
| 2022 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053947
| 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 |
