NCT04197973

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
225

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 13, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

December 18, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

September 3, 2020

Status Verified

September 1, 2020

Enrollment Period

1 year

First QC Date

November 29, 2019

Last Update Submit

September 2, 2020

Conditions

Quality of LifeUlcerative Colitis

Keywords

SCCAIhealth-related quality of life index

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (3)

  • Correlation between self-administered SCCAI and SCCAI assessed by physician

    Baseline

  • Correlation between self-administered SCCAI and SCCAI assessed by physician

    3 months after baseline

  • Correlation between self-administered SCCAI and SCCAI assessed by physician

    6 months after baseline

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KeimyungUniversity

Daegu, Dalseo-gu, 42601, South Korea

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Yoo Jin Lee, Professor

    Keimyung University Dongsan Medical Center

    STUDY DIRECTOR

Central Study Contacts

Yoo Jin Lee, Professor

CONTACT

82-53-258-4341doctorlyj@naver.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 29, 2019

First Posted

December 13, 2019

Study Start

December 18, 2019

Primary Completion

December 20, 2020

Study Completion

December 30, 2020

Last Updated

September 3, 2020

Record last verified: 2020-09

Locations

KR(1)