## Protocol Section
### Identification Module
**NCT ID:** NCT04387279

**Brief Title:** The Impact of COVID-19 on the Health Care Utilization of Inflammatory Bowel Disease

**Official Title:** The Effect of Patient's Perceptions for COVID-19 on the Inflammatory Bowel Disease-related Healthcare Utilization in the Hyperepidemic Area

#### Organization Study ID Info
**ID:** 2020-04-070
#### Organization
**Class:** OTHER
**Full Name:** Keimyung University Dongsan Medical Center
### Status Module
#### Completion Date
**Date:** 2021-03-30

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2020-05-13

**Type:** ACTUAL

**Last Update Submit Date:** 2020-05-12

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2021-03-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-04-24

**Type:** ACTUAL

**Status Verified Date:** 2020-05

#### Study First Post Date
**Date:** 2020-05-13
**Type:** ACTUAL
**Study First Submit Date:** 2020-05-12
**Study First Submit QC Date:** 2020-05-12
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Yeungnam University College of Medicine

#### Lead Sponsor

**Class:** OTHER

**Name:** Keimyung University Dongsan Medical Center

#### Responsible Party

**Investigator Affiliation:** Keimyung University Dongsan Medical Center

**Investigator Full Name:** YooJin Lee

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The rapid spread of COVID-19 is expected to have a significant impact on medicine as well as all sectors worldwide. In particular, inflammatory bowel disease (IBD) is a chronic immune disease in which remission and activation are repeated and must be treated consistently throughout life. In addition, patients with IBD may be vulnerable to various infectious diseases due to the immuno-compromised state due to the use of immuno-suppressants or biological agents. During a pandemic, patients with IBD may postpone hospital visits due to concerns about infection with COVID-19, and if they cannot continue drug treatment, there is a concern about the flare up IBD disease activity. Therefore, in this study, we would like to investigate the current status of hospital utilization of IBD patients in Daegu, the epidemic area of COVID-19, and to investigate the effect of patient perception of COVID-19 on hospital ultilization.

**Detailed Description:** Background: In the epidemic area of COVID-19, emergency treatment of chronic diseases other than COVID-19 can be limited. Therefore, it is important to reduce the risk of exposure to COVID-19 in patients with chronic immune diseases such as IBD, but it is most important to manage well so that the underlying diseases are not exacerbated at times when emergency medical treatment may be difficult. However, there is a lack of evidence on the management policy of chronic immune diseases in the current epidemic, and only expert opinions are being presented.

Aim: To investigate the current status of hospital utilization of IBD patients in Daegu, the epidemic area of COVID-19, and to investigate the effect of patient perception of COVID-19 on hospital utilization.

Material and method: This study is a multicenter, prospective, cross-sectional survey which will be consulted in Keimyung University Dongsan Medical Center and Yeungnam University Hospital. Patients with IBD aged above 18 will enrolled and surveyed about their perception about COVID-19 and status of hospital utilization during pandemic period. Patients' demographics and disease-related variables will be evaluated to identify clinical significances.

### Conditions Module

**Conditions:**

- COVID-19

- Perception, Self

- Facilities and Services Utilization

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 800

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients with inflammatory bowel disease who live in COVID-19 hyperemic area

**Intervention Names:**

- Other: Interview

**Label:** Inflammatory bowel disease

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Inflammatory bowel disease

**Description:** Surveys on medical use patterns and patient's perceptions about COVID-19

**Name:** Interview

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Correlation between patient's perception of COVID-19 and medical use patterns during the pandemic period

**Measure:** Patient's perception of COVID-19 and medical use patterns

**Time Frame:** 1day

#### Secondary Outcomes

**Description:** Exacerbation of symptoms in patients with IBD during the pandemic period

**Measure:** Exacerbation of symptoms

**Time Frame:** 1day

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients with inflammatory growth disease, those who agreed to participate in this study

Exclusion Criteria:

* Those who are unable to understand or answer the questionnaire
* Those who declined to participate in this study

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** This study population will comprise the sample of all patients with inflammatory bowel disease, living in the Daegu city

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** doctorlyj@naver.com

**Name:** Yoojin Lee, M.D.

**Phone:** 82-53-258-7739

**Role:** CONTACT

**Contact 2:**

**Email:** kokim@yu.ac.kr

**Name:** Kyeong Ok Kim, Ph.D.

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Daegu

**Contacts:**

***Contact 1:***

- **Email:** doctorlyj@naver.com

- **Name:** Yoo Jin Lee

- **Phone:** +82-250-7088

- **Role:** CONTACT

**Country:** Korea, Republic of

**Facility:** KeimyungUniversity

**State:** Jung-gu

**Status:** RECRUITING

**Zip:** 700-712

#### Overall Officials

**Official 1:**

**Affiliation:** Keimyung University Dongsan Medical Center

**Name:** Yoojin Lee, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011024

- Term: Pneumonia, Viral

- ID: D000011014

- Term: Pneumonia

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000018352

- Term: Coronavirus Infections

- ID: D000003333

- Term: Coronaviridae Infections

- ID: D000030341

- Term: Nidovirales Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005759

- Term: Gastroenteritis

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M2561

- Name: COVID-19

- Relevance: HIGH

- As Found: COVID-19

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17917

- Name: Inflammatory Bowel Diseases

- Relevance: HIGH

- As Found: Inflammatory Bowel Disease

- ID: M13904

- Name: Pneumonia

- Relevance: LOW

- As Found: Unknown

- ID: M13914

- Name: Pneumonia, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20490

- Name: Coronavirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6555

- Name: Coronaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M23685

- Name: Nidovirales Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8875

- Name: Gastroenteritis

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000086382

- Term: COVID-19

- ID: D000015212

- Term: Inflammatory Bowel Diseases

### Misc Info Module

- Version Holder: 2024-05-24
