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

Quality of Life Clinical Trial

— UC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04197973
• Other study ID #: 2018-05-056
• Status: Recruiting
• Start date: December 18, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: September 2020
• Source: Keimyung University Dongsan Medical Center
• Contact: Yoo Jin Lee, Professor
• Phone: 82-53-258-4341
• Email: doctorlyj[@]naver.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: December 30, 2020
• Est. primary completion date: December 20, 2020
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Quality of Life
• Ulcer
• Ulcerative Colitis

Locations

Country	Name	City	State
Korea, Republic of	KeimyungUniversity	Daegu	Dalseo-gu

Sponsors (5)

Lead Sponsor	Collaborator
YooJin Lee	Gangnam Severance Hospital, Inje University, Jeju National University Hospital, Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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