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

September 2, 2020 updated by: YooJin Lee

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

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.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

225

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

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
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
Baseline
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
3 months after baseline
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
6 months after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline
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
3 months after baseline
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
6 months after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

YooJin Lee

Collaborators

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

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2019

Primary Completion (Anticipated)

December 20, 2020

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

November 29, 2019

First Submitted That Met QC Criteria

December 12, 2019

First Posted (Actual)

December 13, 2019

Study Record Updates

Last Update Posted (Actual)

September 3, 2020

Last Update Submitted That Met QC Criteria

September 2, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-05-056

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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