UMIN-CTR Clinical Trial

Basic information
Public title	Effects of an Education Program to Improve Knowledge and Attitudes and Employment Related to Schizophrenia among Employers
Acronym	Knowledge and Attitudes about Schizophrenia among Employers in Japan
Scientific Title	Effects of an Education Program to Improve Knowledge and Attitudes and Employment Related to Schizophrenia among Employers
Scientific Title:Acronym	Knowledge and Attitudes about Schizophrenia among Employers in Japan
Region	Japan

Condition
Condition	Schizophrenia
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We develop an educational program to increase knowledge of schizophrenia and reduce stigma and then test its effectiveness among employers.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The Basic Knowledge of Schizophrenia scale (BKS)
Key secondary outcomes	Knowledge of Illness and Drugs Inventory (KIDI) scale Link's Devaluation Discrimination Measure (DDM) Work place Social Distance Scale Social Distance Scale Japanese version Attitudes toward hiring persons with schizophrenia among Employers

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are 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	Intervention group; Education
Interventions/Control_2	Non-intervention group
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	Not applicable
Gender	Male and Female
Key inclusion criteria	We screened participants to extract a list of those from private companies who were aged 20 years or older and who had agreed to answer questions about their own or family members' mental health issues.
Key exclusion criteria	Less than 20 years old
Target sample size	4000

Research contact person
Name of lead principal investigator	1st name Hatsumi Middle name - Last name Yoshii
Organization	Tohoku University, Graduate School of Medicine
Division name	Health Sciences
Zip code	980-8575
Address	2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL	0227177954
Email	hatsumi@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Hatsumi Middle name - Last name Yoshii
Organization	Tohoku University, Graduate School of Medicine
Division name	Health Sciences
Zip code	980-8575
Address	2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL	0227177954
Homepage URL
Email	hatsumi@med.tohoku.ac.jp

Sponsor
Institute	Health Sciences, Tohoku University, Graduate School of Medicine
Institute
Department

Funding Source
Organization	Health Science Center
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	-
Address	-
Tel	-
Email	-

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	2017 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	1877
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	Main results already published
Date of protocol fixation	2017 Year 04 Month 27 Day
Date of IRB	2014 Year 06 Month 27 Day
Anticipated trial start date	2017 Year 07 Month 01 Day
Last follow-up date	2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 06 Month 09 Day
Last modified on	2021 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031738