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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044680
Receipt No. R000051024
Scientific Title Consensus development of the outcome items in community mental health research in Japan, which is considered important by both service user and caregivers with mental illness and multiple stakeholders: online Delphi study
Date of disclosure of the study information 2021/07/01
Last modified on 2021/06/28

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Basic information
Public title Consensus development of the outcome items in community mental health research in Japan, which is considered important by both service user and caregivers with mental illness and multiple stakeholders
Acronym Consensus development of the outcome items for community mental health research by multiple stakeholders in Japan
Scientific Title Consensus development of the outcome items in community mental health research in Japan, which is considered important by both service user and caregivers with mental illness and multiple stakeholders: online Delphi study
Scientific Title:Acronym Consensus development of the outcome items for community mental health research by multiple stakeholders in Japan: online Delphi study
Region
Japan

Condition
Condition mental health illness
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore consensus on important and high-priority outcome items for multiple stakeholders such as service users, caregivers, service providers, national and regional government staff, and researchers in community mental health care research in Japan.
Basic objectives2 Others
Basic objectives -Others Not applicable
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Proportion of scores for each item answered by the participants and whether or not consensus was reached
Key secondary outcomes Distribution of scores for each stakeholder

Base
Study type Others,meta-analysis etc

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 The inclusion criteria for service users are: (1) diagnosis of mental illness (potential participants with dementia and intellectual disability are excluded from participation), (2) disability that affects daily life (serious mental illness), and (3) use of community mental health and social services.
The inclusion criteria for caregivers are: (1) primary caregiver for a service user.
The inclusion criteria for community mental health service providers are: (1) national license in medical health and welfare that have (doctor, nurse, psychiatric social worker, occupational therapist, clinical psychologist, and other) and (2) history of involvement in community mental health and welfare services.
The inclusion criteria for national or regional government staff are: (1) working for a government agency and (2) involvement in work related to community mental health and social services.
The inclusion criteria for researchers are: (1) doing research in the field of community mental health care.
Key exclusion criteria (1) age under 20 years
(2) current hospitalization
(3) adult guardianship
Target sample size 250

Research contact person
Name of lead principal investigator
1st name Takuma
Middle name
Last name Shiozawa
Organization National Center of Neurology and Psychiatry
Division name National Institute of mental Health, Department of Community Mental Health & Law
Zip code 187-8553
Address 4-1-1 Ogawahigashi, Kodaira, Tokyo, 187-8553,Japan
TEL 042-341-2711(6284)
Email t.shiozawa@ncnp.go.jp

Public contact
Name of contact person
1st name Takuma
Middle name
Last name Shiozawa
Organization National Center of Neurology and Psychiatry
Division name National Institute of mental Health, Department of Community Mental Health & Law
Zip code 187-9553
Address 4-1-1 Ogawahigashi, Kodaira, Tokyo, 187-8553,Japan
TEL 042-341-2711(6284)
Homepage URL https://www.ncnp.go.jp/nimh/chiiki/research/32.html
Email t.shiozawa@ncnp.go.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization National Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Tokyo Metropolitan University, Graduate School of Human Health Sciences, Department of Nursing Sciences
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Center of Neurology and Psychiatry
Address 4-1-1 Ogawahigashi, Kodaira, Tokyo, 187-8553,Japan
Tel 042-341-2711(6284)
Email t.shiozawa@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
2021 Year 07 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
2021 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2021 Year 07 Month 15 Day
Last follow-up date
2021 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2021 Year 11 Month 30 Day

Other
Other related information Not applicable

Management information
Registered date
2021 Year 06 Month 28 Day
Last modified on
2021 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051024

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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