UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025648
Receipt number R000029506
Scientific Title Test for psychometric properties of the Japanese version of individualized supported employment fidelity scale: a longitudinal study
Date of disclosure of the study information 2017/01/12
Last modified on 2023/09/19 14:21:19

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Basic information

Public title

Test for psychometric properties of the Japanese version of individualized supported employment fidelity scale: a longitudinal study

Acronym

Validity of individualized supported employment fidelity scale

Scientific Title

Test for psychometric properties of the Japanese version of individualized supported employment fidelity scale: a longitudinal study

Scientific Title:Acronym

Validity of individualized supported employment fidelity scale

Region

Japan


Condition

Condition

Mental illness

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To test predictive validity of Japanese version of individualized supported employment fidelity scale

Basic objectives2

Others

Basic objectives -Others

To test predictive validity of Japanese version of individualized supported employment fidelity scale through comparison between the fidelity score of each agency at baseline and employment outcomes at 24-months follow-up

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Employment statue during 24 months follow-up

Key secondary outcomes

Job tenure during 24 months follow-up
Incomes during 24 months follow-up
Hospital admission during 24 months follow-up
Quality of services over the 12 month follow-up (INSPIRE)
Well-being over the 24 month follow-up (WHO5)


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Gender

Male and Female

Key inclusion criteria

Users who met the following criteria;

1. Users in agencies where receive/have received fidelity assessment for Japanese version of individualized supported employment fidelity scale

2. New users in each agencies between 1st January 2017 and 30th June 2017

3. Those who are more than 20 year-old

All the users who meet the above criteria are potential participants for this study. We do not set the target sample size, and just write '0' in the section of sample size, because we have to write the particular number in this section.

Key exclusion criteria

None

Target sample size

0


Research contact person

Name of lead principal investigator

1st name Sosei
Middle name
Last name Yamaguchi

Organization

National Center of Neurology and Psychiatry

Division name

Department of Community Mental Health & Law, National Institute of Mental Health

Zip code

187-8553

Address

4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8553, Japan

TEL

042-346-2039

Email

sosei.yama@ncnp.go.jp


Public contact

Name of contact person

1st name Sosei
Middle name
Last name Yamaguchi

Organization

National Center of Neurology and Psychiatry

Division name

Department of Community Mental Health & Law, National Institute of Mental Health

Zip code

187-8553

Address

4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8553, Japan

TEL

042-346-2168

Homepage URL

http://www.ncnp.go.jp/nimh/fukki/research/05.html

Email

sosei.yama@ncnp.go.jp


Sponsor or person

Institute

National Center of Neurology and Psychiatry

Institute

Department

Personal name



Funding Source

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Center of Neurology and Psychiatry

Address

4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8553, Japan

Tel

042-341-2712

Email

rinri-jimu@ncnp.go.jp


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 01 Month 12 Day


Related information

URL releasing protocol

https://ncnp.bvits.com/rinri/Apply/show.aspx?TYPE=1&ID=1906

Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1007/s10488-021-01161-3

Number of participants that the trial has enrolled

211

Results

The high JiSEF score group obtained higher employment rate (around 70%), compared to the low fidelity score group (around 40%). Also, the high fidelity group produced longer work tenure and greater salary, compared to the low fidelity score group. However, there were not significant differences in rehospitalization, WHO-5 and INSPIRE.

Results date posted

2020 Year 07 Month 16 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 09 Month 02 Day

Baseline Characteristics

Among all participants, 45% of them were female. The mean age was 35. The most common diagnosis was schizophrenia.

Participant flow

16 agencies participated in this study. 211 participants agreed with the participation in this study. 8 had withdrawn their consent or had been identified as violation of inclusion criteria after the study launched.

Adverse events

None

Outcome measures

Employment, work tenure, salary, other vocational-related outcome, rehospitalization, WHO-5, INSPIRE

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 09 Month 01 Day

Date of IRB

2016 Year 09 Month 20 Day

Anticipated trial start date

2017 Year 01 Month 01 Day

Last follow-up date

2019 Year 06 Month 30 Day

Date of closure to data entry

2019 Year 12 Month 31 Day

Date trial data considered complete

2020 Year 06 Month 30 Day

Date analysis concluded

2021 Year 01 Month 31 Day


Other

Other related information

This study aims to explore association between the score for Japanese version of individualized supported employment fidelity scale and employment outcomes in 17 employment service agencies.
We follow all the users who start receiving services in 17 agencies between 1st January 2017 and 30th June 2017.
After 24 months follow-up, we compare employment outcome (Job gain/not, work tenure and so on) and psychological scale (INSPIRE, WHO5) as the score of fidelity scale is an exposure.


Management information

Registered date

2017 Year 01 Month 12 Day

Last modified on

2023 Year 09 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029506


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name