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Association Between Self-reported Web-based SCCAI and Health-related Quality of Life Index in UC Patients (UC)

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ClinicalTrials.gov Identifier: NCT04197973
Recruitment Status : Unknown
Verified September 2020 by YooJin Lee, Keimyung University Dongsan Medical Center.
Recruitment status was:  Recruiting
First Posted : December 13, 2019
Last Update Posted : September 3, 2020
Sponsor:
Collaborators:
Inje University
Gangnam Severance Hospital
Jeju National University Hospital
Soonchunhyang University Hospital
Information provided by (Responsible Party):
YooJin Lee, Keimyung University Dongsan Medical Center

Study Description
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Brief 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. 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.

Condition or disease
Quality of Life Ulcerative Colitis

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
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Study Type : Observational
Estimated Enrollment : 225 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : December 18, 2019
Estimated Primary Completion Date : December 20, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. Correlation between self-administered SCCAI and SCCAI assessed by physician [ Time Frame: Baseline ]
    Correlation between SCCAI administered by a web-based input tool at home and SCCAI assessed by physician

  2. Correlation between self-administered SCCAI and SCCAI assessed by physician [ Time Frame: 3 months after baseline ]
    Correlation between SCCAI administered by a web-based input tool at home and SCCAI assessed by physician

  3. Correlation between self-administered SCCAI and SCCAI assessed by physician [ Time Frame: 6 months after baseline ]
    Correlation between SCCAI administered by a web-based input tool at home and SCCAI assessed by physician


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • diagnosis of UC for >3 months
  • familiarity with online communication (e.g., use of the Internet)
  • Consent for study participation

Exclusion Criteria:

  • Previous colon resection or other UC related bowel surgery
  • Psychiatric or intellectual disability
  • Lack of ability for access or use online tools
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04197973


Contacts
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Contact: Yoo Jin Lee, Professor 82-53-258-4341 doctorlyj@naver.com

Locations
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Korea, Republic of
KeimyungUniversity Recruiting
Daegu, Dalseo-gu, Korea, Republic of, 42601
Contact: Yoo Jin Lee    +82-258-4739    doctorlyj@naver.com   
Sponsors and Collaborators
YooJin Lee
Inje University
Gangnam Severance Hospital
Jeju National University Hospital
Soonchunhyang University Hospital
Investigators
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Study Director: Yoo Jin Lee, Professor Keimyung University Dongsan Medical Center
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: YooJin Lee, Professor, Keimyung University Dongsan Medical Center
ClinicalTrials.gov Identifier: NCT04197973    
Other Study ID Numbers: 2018-05-056
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by YooJin Lee, Keimyung University Dongsan Medical Center:
SCCAI
health-related quality of life index
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases