UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041191 |
|---|---|
| Receipt number | R000047033 |
| Scientific Title | Questionnaire survey on anxiety and behavioral changes in Japanese patients with inflammatory bowel disease caused by the COVID-19 pandemic |
| Date of disclosure of the study information | 2020/07/27 |
| Last modified on | 2022/11/25 00:20:05 |
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Basic information
Public title
Questionnaire survey on anxiety and behavioral changes in Japanese patients with inflammatory bowel disease caused by the COVID-19 pandemic
Acronym
Japan COVID-19 Survey and Questionnaire
in inflammatory bowel disease (J-DESIRE)
Scientific Title
Questionnaire survey on anxiety and behavioral changes in Japanese patients with inflammatory bowel disease caused by the COVID-19 pandemic
Scientific Title:Acronym
Japan COVID-19 Survey and Questionnaire
in inflammatory bowel disease (J-DESIRE)
Region
| Japan |
Condition
Condition
inflammatory bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the anxiety and behavioral changes associated with COVID-19 in Japanese patients with inflammatory bowel disease.
Basic objectives2
Others
Basic objectives -Others
To clarify the COVID-19-related anxiety and behavioral changes that occurred among Japanese patients with inflammatory bowel disease then during treatment by questionnaire survey.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Anxiety felt by patients with inflammatory bowel disease due to the COVID-19 pandemic
Key secondary outcomes
Whether there is a change in the consultation behavior or medication of patients with inflammatory bowel disease due to COVID-19 pandemic
Relationship between anxiety felt by patients with inflammatory bowel disease due to the COVID-19 pandemic and their background and residence
Relationship between consultation behavior and drug changes in patients with inflammatory bowel disease due to the COVID-19 pandemic and their background and residence
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with ulcerative colitis or Crohn's disease
Patients whom we get informed consent
Key exclusion criteria
Patients with Inflammatory bowel disease, unclassified patients
Patients who refused to participate in this study
Patients judged to be ineligible by the research director
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nakase |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8543
Address
South 1 West 16, Chuo-ku, Sapporo, Japan
TEL
011-611-2111
hiropynakase@gmail.com
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Wagatsuma |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8543
Address
South 1 West 16, Chuo-ku, Sapporo, Japan
TEL
011-611-2111
Homepage URL
k.wagatsuma@sapmed.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare of Japan (Investigation and Research for intractable Inflammatory Bowel Disease)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Section, Research Support Section, Secretariat, Sapporo Medical University
Address
South 1 West 17, Chuo-ku, Sapporo, Japan
Tel
011-611-2111
ji-rskk@sapmed.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
東京大学 医科学研究所 先端医療開発推進分野/TR・治験センター（東京都）、杏林大学医学部附属病院 消化器内科（東京都）、旭川医科大学病院 内科学講座 消化器・血液腫瘍制御内科学分野（北海道）、医療法人潤愛会 鮫島病院（鹿児島県）、岩手医科大学附属病院 消化管内科（岩手県）、浦添総合病院 消化器病センター（沖縄県）、大阪大学医学部附属病院 消化器内科（大阪府）、岡山大学病院 炎症性腸疾患センター（岡山県）、香川県立中央病院 消化器内科（香川県）、関西医科大学附属病院 消化器肝臓内科（大阪府）、佐賀大学附属病院 光学医療診療部（佐賀県）、札幌IBDクリニック（北海道）、札幌医科大学医学部 消化器内科学講座（北海道）、札幌厚生病院 消化器内科IBDセンター（北海道）、札幌東徳洲会病院 IBDセンター（北海道）、獨協医科大学病院 消化器内科（栃木県）、島根大学医学部内科学講座（島根県）、辻仲病院柏の葉 消化器内科・IBDセンター（千葉県）、東京慈恵会医科大学附属病院 消化器・肝臓内科（東京都）、東邦大学医療センター佐倉病院 消化器内科学（千葉県）、東北医科薬科大学医学部 内科学第二（消化器内科）（宮城県）、東北大学 消化器内科（宮城県）、富山県立中央病院 消化器内科（富山県）、名古屋大学医学部附属病院 消化器内科（愛知県）、新潟大学医歯学総合病院 消化器内科学分野（新潟県）、浜松医科大学医学部附属病院 消化器内科（静岡県）、兵庫医科大学病院 炎症性腸疾患内科（兵庫県）、弘前大学大学院医学研究科 消化器血液内科学講座（青森県）、福岡大学医学部 消化器内科（福岡県）、福岡大学筑紫病院 消化器内科（福岡県）、藤田保健衛生大学病院 消化管内科（愛知県）、防衛医科大学校病院 消化器内科（埼玉県）、松山赤十字病院 胃腸センター（愛媛県）、横浜市立大学附属市民総合医療センター 炎症性腸疾患センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The patient sends a questionnaire directly to the Department of Gastroenterology and Hepatology, Sapporo Medical University School of Medicine. The data is registered at the Department of Gastroenterology and Hepatology, Sapporo Medical University School of Medicine. The registered data are sent to the Institute of Medical Science, University of Tokyo for statistical analysis.
Management information
Registered date
| 2020 | Year | 07 | Month | 22 | Day |
Last modified on
| 2022 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047033
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
