UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035793 |
|---|---|
| Receipt number | R000040773 |
| Scientific Title | Evaluation for the relationship between mental health disorders and academic achievement or promotion using a simple questionnaire in medical university students. |
| Date of disclosure of the study information | 2019/03/01 |
| Last modified on | 2024/08/16 12:01:21 |
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Basic information
Public title
Evaluation for the relationship between mental health disorders and academic achievement or promotion using a simple questionnaire in medical university students.
Acronym
Evaluation for mental health disorders and academic achievement.
Scientific Title
Evaluation for the relationship between mental health disorders and academic achievement or promotion using a simple questionnaire in medical university students.
Scientific Title:Acronym
Evaluation for mental health disorders and academic achievement.
Region
| Japan |
Condition
Condition
Mental health disorders
Classification by specialty
| Neurology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationship between mental health disorders and academic achievement in medical university students.
Basic objectives2
Others
Basic objectives -Others
To evaluate the relationship between developmental disorders and academic achievement in medical university students.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between scores of the Kessler Psychological Distress (K6) questionnaire and academic achievement.
Key secondary outcomes
The relationship between scores of developmental disorders and academic achievement.
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
Students in Hamamatsu university school of medicine.
Key exclusion criteria
Students on a leave of absence.
Students who do not want to participate in this study.
Students who a school doctor judged as inappropriate for this study.
Target sample size
1540
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Enomoto |
Organization
Hamamatsu University School of Medicine
Division name
Health Administration Center
Zip code
4313192
Address
1-20-1 Handayama, Higashiku, Hamamatsu, Japan
TEL
053-435-2158
norieno@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Enomoto |
Organization
Hamamatsu University School of Medicine
Division name
Health Administration Center
Zip code
4313192
Address
1-20-1 Handayama, Higashiku, Hamamatsu, Japan
TEL
053-435-2158
Homepage URL
norieno@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
Hamamatsu University School of Medicne
Address
1-20-1 Handayama, Higashiku, Hamamatsu, Shizuoka, Japan
Tel
0534352158
norieno@hama-med.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
| 2019 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.hama-med.ac.jp/research/18-301.pdf
Publication of results
Unpublished
Result
URL related to results and publications
https://jglobal.jst.go.jp/detail?JGLOBAL_ID=202202270640528143
Number of participants that the trial has enrolled
1091
Results
Forty-five students (2.4%) were repeated a year at university and 26 (57.8%) students answered to the questionnaire. Repeating a year was frequently found in lower grade students. The simple questionnaire revealed that 10 points or more score of Kessler 6 questionnaire, insomnia, suicidal ideation, scores of ADHD factors were significant factors for repeating a year at school.
Results date posted
| 2024 | Year | 08 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Students in University school of medicine.
Participant flow
In this study, 1091 medical students, who gave informed consents, were enrolled. Students were asked by using the simple questionnaire, including Kessler 6 questionnaire, insomnia, suicidal ideation, scores of ASD or ADHD factors on April and September. Students were prospectively followed up.
Adverse events
None
Outcome measures
Repeating a year at school.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2019 | Year | 02 | Month | 06 | Day |
Last modified on
| 2024 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040773
