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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047436
Receipt No. R000054094
Scientific Title An observational study of the characteristics of clinical findings and medical data and the effectiveness of professional support for athletes visiting a mental health outpatient clinic
Date of disclosure of the study information 2022/06/16
Last modified on 2022/04/08

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Basic information
Public title Medical research using clinical findings and medical data of patients who visited the Athlete Mental Support Outpatient Clinic
Acronym Observational Study of Athlete Mental Outpatient Clinic Data
Scientific Title An observational study of the characteristics of clinical findings and medical data and the effectiveness of professional support for athletes visiting a mental health outpatient clinic
Scientific Title:Acronym Observational Study of Athlete Mental Outpatient Clinic Data
Region
Japan

Condition
Condition Mental illness in athletes
Classification by specialty
Psychosomatic Internal Medicine Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify characteristics and trends of athletes' mental health outpatient visits
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes demographics for outpatient visits of athletes mental health
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who have visited the Outpatient Clinic for Athlete Mental Support, Institute for Integrated Sports Medicine, Keio University Hospital
Key exclusion criteria Patients who did not give consent to cooperate in an observational study
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Yoshinori
Middle name
Last name Katsumata
Organization Keio University
Division name Institute for Integrated Sports Medicine
Zip code 1608582
Address Shinanomachi, Shinjuku-ku, Tokyo
TEL 0352699054
Email tatsuyamaguchi@keio.jp

Public contact
Name of contact person
1st name Tatsuya
Middle name
Last name Yamaguchi
Organization Keio University
Division name Institute for Integrated Sports Medicine
Zip code 1608582
Address Shinanomachi, Shinjuku-ku, Tokyo
TEL 0352699054
Homepage URL
Email tatsuyamaguchi@keio.jp

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization Keio University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Ethical Committee of Keio University
Address Shinanomachi, Shinjuku-ku, Tokyo
Tel 03-5363-3961
Email med-rinri-jimu@adst.keio.ac.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
2022 Year 06 Month 16 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
2022 Year 03 Month 16 Day
Date of IRB
Anticipated trial start date
2022 Year 05 Month 31 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational studies using medical information in electronic health records

Management information
Registered date
2022 Year 04 Month 08 Day
Last modified on
2022 Year 04 Month 08 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054094

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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