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

• ClinicalTrials.gov Identifier: NCT04197973
• Recruitment Status: Unknown
• First Posted: December 13, 2019
• Last Update Posted: September 3, 2020
• Sponsor: YooJin Lee
• 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

Tracking Information

• First Submitted Date: November 29, 2019
• First Posted Date: December 13, 2019
• Last Update Posted Date: September 3, 2020
• Actual Study Start Date: December 18, 2019
• Estimated Primary Completion Date: December 20, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 12, 2019)

• 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
• 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
• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 12, 2019)

• 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
• 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
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Quality of Life
• Ulcerative Colitis

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: December 12, 2019): 225
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 30, 2020
• Estimated Primary Completion Date: December 20, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT04197973
• Other Study ID Numbers: 2018-05-056
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: YooJin Lee, Keimyung University Dongsan Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: YooJin Lee
• Original Study Sponsor: Same as current

Collaborators

• Inje University
• Gangnam Severance Hospital
• Jeju National University Hospital
• Soonchunhyang University Hospital

Investigators

• Study Director: Yoo Jin Lee, Professor; Keimyung University Dongsan Medical Center

• PRS Account: Keimyung University Dongsan Medical Center
• Verification Date: September 2020