UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047436 |
|---|---|
| Receipt number | 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 | 2022/10/08 11:50:38 |
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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
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
tatsuyamaguchi@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
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
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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 03 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 31 | Day |
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 | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054094
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
