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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Association Between Self-reported Web-based Simple Clinical Colitis Activity Index(SCCAI) and Health-related Quality of Life Index in Patients With Ulcerative Colitis

Conditions
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Quality of Life, Ulcerative Colitis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 6 months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 6 months after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SCCAI, health-related quality of life index