COVID-19NCT04387279
The Impact of COVID-19 on the Health Care Utilization of Inflammatory Bowel Disease
An observational study of COVID-19 and Perception, Self, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Perception, Self, Facilities and Services Utilization
- What is being tested?
- Interview
- How many people
- 800 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Apr 2020to 30 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study population will comprise the sample of all patients with inflammatory bowel disease, living in the Daegu city
Who may be able to join
- Patients with inflammatory growth disease, those who agreed to participate in this study
Who cannot join
- Those who are unable to understand or answer the questionnaire
- Those who declined to participate in this study
Trial locations and contacts
1 site in 1 country.
Kyeong Ok Kim, Ph.D. contact
South Korea1 site, 1 recruiting
- Recruiting
KeimyungUniversity
Daegu, Jung-gu, 700-712
Yoo Jin Lee, +82-250-7088, doctorlyj@naver.com
About this study
Official title: The Effect of Patient's Perceptions for COVID-19 on the Inflammatory Bowel Disease-related Healthcare Utilization in the Hyperepidemic Area
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.
Read the 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.
- Being tested
- Interview
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Surveys on medical use patterns and patient's perceptions about COVID-19
| Study group | Role | What they receive |
|---|---|---|
| Inflammatory bowel disease | Patients with inflammatory bowel disease who live in COVID-19 hyperemic area Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's perception of COVID-19 and medical use patterns
Correlation between patient's perception of COVID-19 and medical use patterns during the pandemic period
Measured: 1day
Secondary outcomes (1)
Exacerbation of symptoms
Exacerbation of symptoms in patients with IBD during the pandemic period
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start24 Apr 2020
- Primary completion30 Mar 2021 (estimated)
- Study completion30 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Yeungnam University College of Medicine
- Responsible party
- Principal investigator, YooJin Lee, Keimyung University Dongsan Medical Center
- Investigators
- Yoojin Lee, M.D., Principal investigator, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387279
- Sponsor's protocol ID
- 2020-04-070
- Status last verified
- May 2020
- First submitted
- 12 May 2020
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Patient's Perceptions for COVID-19 on the Inflammatory Bowel Disease-related Healthcare Utilization in the Hyperepidemic Area
- ClinicalTrials.gov ID
- NCT04387279
- Acronym / sponsor ID
- 2020-04-070
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Collaborators
- Yeungnam University College of Medicine
- Study start
- 24 Apr 2020 (actual)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 30 Mar 2021 (estimated)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inflammatory bowel disease | – | Other: InterviewPatients with inflammatory bowel disease who live in COVID-19 hyperemic area |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study population will comprise the sample of all patients with inflammatory bowel disease, living in the Daegu city
Key inclusion criteria (1 listed)
- Patients with inflammatory growth disease, those who agreed to participate in this study
Key exclusion criteria (2 listed)
- Those who are unable to understand or answer the questionnaire
- Those who declined to participate in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewSurveys on medical use patterns and patient's perceptions about COVID-19 | Other | Inflammatory bowel disease |
Primary outcome
Patient's perception of COVID-19 and medical use patterns
Time frame: 1day
Correlation between patient's perception of COVID-19 and medical use patterns during the pandemic period
1 secondary outcome
Exacerbation of symptoms
Time frame: 1day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyeong Ok Kim, Ph.D. contact
Yoojin Lee, M.D. principal investigator
Keimyung University Dongsan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Perception, Self, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoojin Lee, M.D. (82-53-258-7739, doctorlyj@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's perception of COVID-19 and medical use patterns (time frame: 1day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.