UMIN-CTR Clinical Trial

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
Email	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
Email	yoshikazu.ishimoto@shionogi.co.jp

Sponsor
Institute	SHIONOGI & CO., LTD.
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049691