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临床试验/NCT04197973
NCT04197973Unknown不适用

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

YooJin Lee1 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2019年12月18日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
225
试验地点
1
主要终点
Correlation between SCCAI and health-related quality of life (IBD-Q 32) in patient with UC

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Previous colon resection or other UC related bowel surgery
  • Psychiatric or intellectual disability
  • Lack of ability for access or use online tools

结局指标

主要结局

Correlation between SCCAI and health-related quality of life (IBD-Q 32) in patient with UC

时间窗: 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

次要结局

  • Correlation between self-administered SCCAI and SCCAI assessed by physician(6 months after baseline)

研究者

发起方
YooJin Lee
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

YooJin Lee

Professor

Keimyung University Dongsan Medical Center

研究点 (1)

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