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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038845
Receipt No. R000044298
Scientific Title Influence on empowerment for a mentally handicapped person participating in the study of mental health and welfare
Date of disclosure of the study information 2019/12/12
Last modified on 2020/07/17

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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