UMIN-CTR Clinical Trial

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
Email	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
Email	wakamatsu-raimu@ed.tmu.ac.jp

Sponsor
Institute	Tokyo Metropolitan University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053947