UMIN-CTR Clinical Trial

Basic information
Public title	Influence on empowerment for a mentally handicapped and not institutionalized person in needing social support, to participate in the study performed by the researcher of mental health and welfare
Acronym	Influence on empowerment for a mentally handicapped and not institutionalized person in needing social support, to participate in the study performed by the researcher of mental health and welfare
Scientific Title	Influence on empowerment for a mentally handicapped person participating in the study of mental health and welfare
Scientific Title:Acronym	Influence on empowerment for a mentally handicapped person participating in the study of mental health and welfare
Region	Japan

Condition
Condition	Mentally handicapped and not institutionalized persons with schizophrenia and emotional disorder
Classification by specialty	Psychiatry Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Construction of program and verifying ability of practice
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Empowerment of pre & post program performing
Key secondary outcomes	Feeling tired

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	3 days' educational program for covering essential knowledge to advice for researcher was carried out and advising to researchers was carried out on a day Each program was held for 2 hours a day, about 3 weeks interval for each program
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	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	Subjects are not institutionalized person, has or had a mental disorder, are essential for social support or care, and interest in participation for the research 1.Not institutionalized and living with or without social support over 2 years 2.Does not have been institutionalized for 2 years by the return of mental disorder 3.Possible for decision of one's life event, such as activity and relaxation, self medication, and administration of one's accounts. 4.Possible to call assistance and to possess the way, on occasion for living problem 5.Not to use an adult guardianship system
Key exclusion criteria	1.With a strong suicidal tendency 2.With an unstable condition
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Junko Middle name Last name Katsuragawa
Organization	TOYOHASHI SOZO University
Division name	Department of Nursing, Faculty of Health and Medical Care
Zip code	440-8511
Address	20-1 Matsushita, Ushikawacho, Toyohashi, Aichi Prefecture
TEL	050-2017-2220
Email	16k15977@gmail.com

Public contact
Name of contact person	1st name Junko Middle name Last name Katsuragawa
Organization	TOYOHASHI SOZO University
Division name	Department of Nursing, Faculty of Health and Medical Care
Zip code	440-8511
Address	20-1 Matsushita, Ushikawacho, Toyohashi, Aichi Prefecture
TEL	050-2017-2220
Homepage URL
Email	16k15977@gmail.com

Sponsor
Institute	TOYOHASHI SOZO University
Institute
Department

Funding Source
Organization	Japan society for the promotion of science Grants-in-Aid for scientific research Grant-in-Aid for Challenging Research Exploratory
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	TOYOHASHI SOZO University
Address	20-1 Matsushita, Ushikawacho, Toyohashi, Aichi Prefecture
Tel	050-2017-2220
Email	16k15977@gmail.com

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	2019 Year 12 Month 12 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	Completed
Date of protocol fixation	2019 Year 10 Month 17 Day
Date of IRB	2019 Year 10 Month 17 Day
Anticipated trial start date	2019 Year 12 Month 15 Day
Last follow-up date	2020 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	2019 Year 12 Month 11 Day
Last modified on	2020 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044298