UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043532 |
|---|---|
| Receipt number | R000049691 |
| Scientific Title | Impact of COVID-19 on working style and daily life of Japanese adult with AD/HD-like symptoms |
| Date of disclosure of the study information | 2021/03/05 |
| Last modified on | 2022/09/20 08:43:42 |
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Basic information
Public title
Impact of COVID-19 on working style and daily life of Japanese adult with AD/HD-like symptoms
Acronym
Impact of COVID-19 on working style and daily life of Japanese adult with AD/HD-like symptoms
Scientific Title
Impact of COVID-19 on working style and daily life of Japanese adult with AD/HD-like symptoms
Scientific Title:Acronym
Impact of COVID-19 on working style and daily life of Japanese adult with AD/HD-like symptoms
Region
| Japan |
Condition
Condition
AD/HD
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating impact of COVID-19 on unemployment, working productivity, depression and quality of life of Japanese adult with AD/HD-like symptoms compared with controls.
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Unemployment rate
PHQ-9
WPAI
EQ-5D
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
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Participants registered with Medilead Healthcare Panel (MHP) who have answers at the survey on December 2019 (past survey)
2. Participants with any kind of work at the time of past survey
3. Participants of aged 20 or over at the time of past survey
4. Participants who did not report a hospital visit due to AD/HD within a year of the time of past survey
Key exclusion criteria
Participants who work at hospital, clinic or pharmacies.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Ishimoto |
Organization
SHIONOGI & CO., LTD.
Division name
Integrated Disease Care Division Medical Affairs Department
Zip code
541-0045
Address
1-8, Doshomachi 3-chome, Chuo-ku, Osaka, 541-0045, Japan
TEL
06-6209-7412
yoshikazu.ishimoto@shionogi.co.jp
Public contact
Name of contact person
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Ishimoto |
Organization
SHIONOGI & CO., LTD.
Division name
Integrated Disease Care Division Medical Affairs Department
Zip code
541-0045
Address
1-8, Doshomachi 3-chome, Chuo-ku, Osaka, 541-0045, Japan
TEL
06-6209-7412
Homepage URL
yoshikazu.ishimoto@shionogi.co.jp
Sponsor or person
Institute
SHIONOGI & CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
SHIONOGI & CO., LTD.
Takeda Pharmaceutical Company Limited.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Takeda Pharmaceutical Company Limited.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
MINS
Address
5-20-9-401, Mita, Minato-Ku, Tokyo, Japan
Tel
03-6416-1868
npo-mins@j-irb.com
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 | 03 | Month | 05 | Day |
Related information
URL releasing protocol
https://doi.org/10.2147/NDT.S358085
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.2147/NDT.S358085
Number of participants that the trial has enrolled
1891
Results
See the article.
Results date posted
| 2022 | Year | 09 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
See the article.
Participant flow
See the article.
Adverse events
See the article.
Outcome measures
See the article.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 22 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 22 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 04 | Month | 30 | Day |
Other
Other related information
A web-based survey on participants registered with Medilead Healthcare Panel (MHP) and meet all eligible criteria.
Management information
Registered date
| 2021 | Year | 03 | Month | 05 | Day |
Last modified on
| 2022 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049691
