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

inflammatory bowel disease

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

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

Email

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

Email

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

Email

ji-rskk@sapmed.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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