Quality of LifeUCNCT04197973
Association Between Self-reported Web-based SCCAI and Health-related Quality of Life Index in UC Patients
An observational study of Quality of Life and Ulcerative Colitis, run by YooJin Lee at 1 site in South Korea.
Trial summary
An accurate assessment of disease activity is crucial for the treatment of patients with ulcerative colitis (UC). Recent studies have reported that the Simple Clinical Colitis Activity Index (SCCAI) correlates well with Mayo score. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Quality of Life, Ulcerative Colitis
- How many people
- 225 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Dec 2019to 30 Dec 2020
- 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 to 65 years
- All sexes
- Adult, Older adult
Study population: Patients with ulcerative colitis visiting Inje University College of Medicine Ilsan Paik Hospital, Gangnam Severance Hospital, Jeju National University Hospital, Keimyung University Dongsan Medical Center, Soonchunhyang University Hospital Cheonan will be eligible.
Who may be able to join
- diagnosis of UC for >3 months
- familiarity with online communication (e.g., use of the Internet)
- Consent for study participation
Who cannot join
- Previous colon resection or other UC related bowel surgery
- Psychiatric or intellectual disability
- Lack of ability for access or use online tools
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
KeimyungUniversity
Daegu, Dalseo-gu, 42601
Yoo Jin Lee, +82-258-4739, doctorlyj@naver.com
About this study
Official title: Association Between Self-reported Web-based Simple Clinical Colitis Activity Index(SCCAI) and Health-related Quality of Life Index in Patients With Ulcerative Colitis
An accurate assessment of disease activity is crucial for the treatment of patients with ulcerative colitis (UC). Recent studies have reported that the Simple Clinical Colitis Activity Index (SCCAI) correlates well with Mayo score. A recent report demonstrated that SCCAI has a significant correlation with the degree of health-related quality of life in UC patients. It is also reported that the self-administered SCCAI through the web-based input tool at home is highly correlated with the SCCAI assessed by physician. The aim of this study was to investigate the relationship between self-administered web-based SCCAI and the health-related quality of life of UC patients.
Read the detailed description
An accurate assessment of disease activity is crucial for the treatment of patients with ulcerative colitis (UC). Several indices have been used to assess disease activity in patients with UC. Mayo score is the most widely used index for UC activity measurement. Meanwhile, recent studies have reported that the Simple Clinical Colitis Activity Index (SCCAI) correlates well with Mayo score. SCCAI is consisted of only clinical items and includes items such as nocturnal diarrhea and urgent defecation which are more closely related to the quality of life of patients. In this regard, a recent report demonstrated that SCCAI has a significant correlation with the degree of health-related quality of life in UC patients.
Since SCCAI is composed of only clinical parameters, it can be evaluated by the patients themselves. According to recent research, the self-administered SCCAI was reported to have a high correlation with the SCCAI assessed by physician (correlation coefficient = 0.79). Moreover, it is also reported that the self-administered SCCAI through the web-based input tool at home is highly correlated with the SCCAI assessed by physician (Spearman's correlation = 0.79). These results suggest that the patient's self-reported SCCAI can be applied to actual clinical practice, and it will enable remote monitoring and flexible follow-up depending on the patient's disease activity. If self-administered SCCAI is to be applied as a more valid disease activity assessment tools, it also properly reflects patient's quality of life status. However, it is not yet known whether the self-administered SCCAI using web-based tools reflects the quality of life of patients.
The aim of this study was to investigate the relationship between self-administered web-based SCCAI and the health-related quality of life of UC patients.
- Conditions
- Quality of Life, Ulcerative Colitis
- Keywords
- SCCAI, health-related quality of life index
- Medical subject headings
- Colitis, Ulcerative
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between SCCAI and health-related quality of life (IBD-Q 32) in patient with UC
Correlation between SCCAI administered by a web-based input tool at home and health-related quality of life (IBD-Q 32) in patient with UC
Measured: Baseline
Correlation between SCCAI and health-related quality of life (IBD-Q 32) in patient with UC
Correlation between SCCAI administered by a web-based input tool at home and health-related quality of life (IBD-Q 32) in patient with UC
Measured: 3 months after baseline
Correlation between SCCAI and health-related quality of life (IBD-Q 32) in patient with UC
Correlation between SCCAI administered by a web-based input tool at home and health-related quality of life (IBD-Q 32) in patient with UC
Measured: 6 months after baseline
Secondary outcomes (3)
Correlation between self-administered SCCAI and SCCAI assessed by physician
Correlation between SCCAI administered by a web-based input tool at home and SCCAI assessed by physician
Measured: Baseline
Correlation between self-administered SCCAI and SCCAI assessed by physician
Correlation between SCCAI administered by a web-based input tool at home and SCCAI assessed by physician
Measured: 3 months after baseline
Correlation between self-administered SCCAI and SCCAI assessed by physician
Correlation between SCCAI administered by a web-based input tool at home and SCCAI assessed by physician
Measured: 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start18 Dec 2019
- Primary completion20 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Prospective
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- YooJin Lee
- Sponsor type
- University, hospital or other
- Collaborators
- Inje University, Gangnam Severance Hospital, Jeju National University Hospital, Soonchunhyang University Hospital
- Responsible party
- Sponsor-investigator, YooJin Lee, Keimyung University Dongsan Medical Center
- Investigators
- Yoo Jin Lee, Professor, Study director, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197973
- Sponsor's protocol ID
- 2018-05-056
- Acronym
- UC
- Status last verified
- Sep 2020
- First submitted
- 29 Nov 2019
- Last updated
- 3 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Self-reported Web-based Simple Clinical Colitis Activity Index(SCCAI) and Health-related Quality of Life Index in Patients With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT04197973
- Acronym / sponsor ID
- UC / 2018-05-056
- Conditions
- Quality of Life, Ulcerative Colitis
- Keywords
- SCCAI, health-related quality of life index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- YooJin LeeUniversity, hospital or other
- Collaborators
- Inje University, Gangnam Severance Hospital, Jeju National University Hospital, Soonchunhyang University Hospital
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 20 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 13 Dec 2019 (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.
An accurate assessment of disease activity is crucial for the treatment of patients with ulcerative colitis (UC). Recent studies have reported that the Simple Clinical Colitis Activity Index (SCCAI) correlates well with Mayo score. A recent report demonstrated that SCCAI has a significant correlation with the degree of health-related quality of life in UC patients. It is also reported that the self-administered SCCAI through the web-based input tool at home is highly correlated with the SCCAI assessed by physician. The aim of this study was to investigate the relationship between self-administered web-based SCCAI and the health-related quality of life of UC patients.
Detailed description
An accurate assessment of disease activity is crucial for the treatment of patients with ulcerative colitis (UC). Several indices have been used to assess disease activity in patients with UC. Mayo score is the most widely used index for UC activity measurement. Meanwhile, recent studies have reported that the Simple Clinical Colitis Activity Index (SCCAI) correlates well with Mayo score. SCCAI is consisted of only clinical items and includes items such as nocturnal diarrhea and urgent defecation which are more closely related to the quality of life of patients. In this regard, a recent report demonstrated that SCCAI has a significant correlation with the degree of health-related quality of life in UC patients.
Since SCCAI is composed of only clinical parameters, it can be evaluated by the patients themselves. According to recent research, the self-administered SCCAI was reported to have a high correlation with the SCCAI assessed by physician (correlation coefficient = 0.79). Moreover, it is also reported that the self-administered SCCAI through the web-based input tool at home is highly correlated with the SCCAI assessed by physician (Spearman's correlation = 0.79). These results suggest that the patient's self-reported SCCAI can be applied to actual clinical practice, and it will enable remote monitoring and flexible follow-up depending on the patient's disease activity. If self-administered SCCAI is to be applied as a more valid disease activity assessment tools, it also properly reflects patient's quality of life status. However, it is not yet known whether the self-administered SCCAI using web-based tools reflects the quality of life of patients.
The aim of this study was to investigate the relationship between self-administered web-based SCCAI and the health-related quality of life of UC patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with ulcerative colitis visiting Inje University College of Medicine Ilsan Paik Hospital, Gangnam Severance Hospital, Jeju National University Hospital, Keimyung University Dongsan Medical Center, Soonchunhyang University Hospital Cheonan will be eligible.
Key inclusion criteria (3 listed)
- diagnosis of UC for >3 months
- familiarity with online communication (e.g., use of the Internet)
- Consent for study participation
Key exclusion criteria (3 listed)
- Previous colon resection or other UC related bowel surgery
- Psychiatric or intellectual disability
- Lack of ability for access or use online tools
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between SCCAI and health-related quality of life (IBD-Q 32) in patient with UC
Time frame: Baseline
Correlation between SCCAI administered by a web-based input tool at home and health-related quality of life (IBD-Q 32) in patient with UC
Correlation between SCCAI and health-related quality of life (IBD-Q 32) in patient with UC
Time frame: 3 months after baseline
Correlation between SCCAI administered by a web-based input tool at home and health-related quality of life (IBD-Q 32) in patient with UC
Correlation between SCCAI and health-related quality of life (IBD-Q 32) in patient with UC
Time frame: 6 months after baseline
Correlation between SCCAI administered by a web-based input tool at home and health-related quality of life (IBD-Q 32) in patient with UC
3 secondary outcomes
Correlation between self-administered SCCAI and SCCAI assessed by physician
Time frame: Baseline
Correlation between self-administered SCCAI and SCCAI assessed by physician
Time frame: 3 months after baseline
Correlation between self-administered SCCAI and SCCAI assessed by physician
Time frame: 6 months after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
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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.
Yoo Jin Lee, Professor study director
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 Quality of Life and Ulcerative Colitis, run by YooJin Lee 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 3 inclusion and 3 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 3 Sep 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 Yoo Jin Lee, Professor (82-53-258-4341, doctorlyj@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between SCCAI and health-related quality of life (IBD-Q 32) in patient with UC (time frame: Baseline). The study lists 3 primary outcomes in all. 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 3 Sep 2020.