UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044680 |
|---|---|
| Receipt number | 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 | 2025/07/01 11:23:47 |
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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)
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
t.shiozawa@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
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)
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
https://doi.org/10.1002/npr2.12211
Publication of results
Unpublished
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/40369819/
Number of participants that the trial has enrolled
297
Results
A diverse group of stakeholders including individuals with mental illness, their families, professionals, government officials, and researchers. Participated in a three round online Delphi survey, achieving a 93.6% response rate. The survey identified 24 key outcome domains and revealed both shared priorities and role-based differences in perceived importance.
Results date posted
| 2025 | Year | 07 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 05 | Month | 14 | Day |
Baseline Characteristics
A total of 54 service users, 59 caregivers, 57 service providers, 60 government officials, and 61 researchers completed the final round of responses.
1.Eligibility Criteria for Service Users
(1) Persons diagnosed with a mental illness and currently living in the community
(2) Persons whose daily or social functioning is restricted due to mental illness (e.g., limited ability to go out or engage in activities due to symptoms, difficulty performing household tasks or maintaining employment, occasional need for support due to poor physical or mental condition, etc. This includes individuals with a Mental Disability Certificate of Grade 3 or higher, or equivalent conditions);
(3) Persons who are currently using, or have previously used, community mental health services.
2. Caregivers
a.Family members (e.g., parents, siblings, children, spouses, etc.) who serve as primary caregivers for individuals meeting the criteria described above, or persons in an equivalent caregiving role.
3. Service Providers
Persons who meet all of the following criteria:
(1) Hold a national qualification for providing community mental health services (e.g., physicians, nurses, psychiatric social workers, occupational therapists, licensed psychologists including clinical psychologists);
(2) Have experience providing community-based mental health services (e.g., psychiatric day care, home visit nursing, outpatient occupational therapy, services under the Comprehensive Support Act, or municipally provided mental health and welfare services).
4. Government Officials
Persons who meet both of the following criteria:
(1) Currently work or have previously worked in a government agency;
(2) Have experience in duties related to community mental health, medical, or welfare services.
5. Researchers
Persons with experience conducting research related to community mental health.
Participant flow
We approached various organisations relevant to community mental health, including groups representing service users, caregivers, professionals, government officials, and academic communities, to explain our study's objectives and content. These organisations were selected based on their active involvement in supporting stakeholders and their relevance to community mental health, ensuring diverse viewpoints in our participant pool. After obtaining cooperation from key individuals within these organisations, they assisted in disseminating study information via organisational mailing lists and email newsletters. Furthermore, individuals who had participated in previous related studies were contacted, along with authors of pertinent original articles focusing on community psychiatry and mental health services in Japan. Recruitment took place between July 12 and August 10, 2021. During the recruitment process, we provided a thorough explanation of the study details and burden associated with participation before requesting voluntary participation. Participants were informed upon recruitment that they would receive 500 yen for each round of participation.
Adverse events
None
Outcome measures
Importance Ratings and Free-Text Comments for Each Outcome Domain
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
| 2025 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051024
