Clinical trial NCT04197973: Association Between Self-reported Web-based SCCAI and Health-related Quality of Life Index in UC Patients
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Life
Ulcerative Colitis
Keywords: SCCAI
health-related quality of life index
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
Collaborators: name: Inje University
name: Gangnam Severance Hospital
name: Jeju National University Hospital
name: Soonchunhyang University Hospital
First posted: 2019-12-13
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Correlation between SCCAI and health-related quality of life (IBD-Q 32) in patient with UC
timeFrame: Baseline
measure: Correlation between SCCAI and health-related quality of life (IBD-Q 32) in patient with UC
timeFrame: 3 months after baseline
measure: Correlation between SCCAI and health-related quality of life (IBD-Q 32) in patient with UC
timeFrame: 6 months after baseline
Secondary outcomes:
measure: Correlation between self-administered SCCAI and SCCAI assessed by physician
timeFrame: Baseline
measure: Correlation between self-administered SCCAI and SCCAI assessed by physician
timeFrame: 3 months after baseline
measure: Correlation between self-administered SCCAI and SCCAI assessed by physician
timeFrame: 6 months after baseline
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: KeimyungUniversity
state: Dalseo-gu
Study officials:
affiliation: Keimyung University Dongsan Medical Center
name: Yoo Jin Lee, Professor
role: STUDY_DIRECTOR
References: