Sick Leave, Work Disability and Quality of Life in Korean Patients With Inflammatory Bowel Diseases

Completed

• Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases; Crohn Disease

• Registration Number: NCT03565432
• Lead Sponsor: Kyunghee University Medical Center

Brief Summary

Inflammatory bowel diseases (IBD) is a chronic inflammatory condition of the gastrointestinal tract that significantly affects quality of life of patients.

Several studies have reported that the loss of work productivity is significantly higher than that of the general population due to disease-related symptoms and various factors in patients with inflammatory bowel disease in Western countries, but there is few data in Korea.

Therefore, this study is to assess the effect of disease on sick leave, work disability and health related quality of life in Korean patients with inflammatory bowel disease by using validated questionnaires.

Detailed Description

First, the investigators will estimate the prevalence of work disability in patients with inflammatory bowel disease using the Work Productivity and Activity Index (WPAI), that have been validated in patients with inflammatory bowel disease.

Secondary, the predictor of work productivity impairment in patients with inflammatory bowel disease and distribution of type and severity of work disability will be identified.

Third, the investigators will explore the correlation between the quality of life and psychosocial aspects (anxiety disorder, depression) of patients with inflammatory bowel disease.

One year later, the same questionnaire will be surveyed repeatedly in the same participants under usual care to investigate the changes in patient-reported outcome measures.

Study Timeline

• Study Start: 2018-03-09
• Study First Submitted: 2018-04-25
• Study First Submitted QC: 2018-06-11
• Study First Posted: 2018-06-21
• Primary Completion: 2019-07-30
• Study Completion: 2020-02-19
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 402

Inclusion Criteria

Patients diagnosed with inflammatory bowel disease (Crohn's disease and ulcerative colitis) at Kyung Hee University Hospital

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Exclusion Criteria

1. Patients who do not agree to fill out the questionnaire.
2. Patients who can not fill out the questionnaire themselves.
3. Patients who can not understand the questionnaire.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Total Percentage of Work Impairment by Work Productivity and Activity Impairment Questionnaire (WPAI) in CD or UC Participants	From initial diagnosis until date of data collection (approximately 1 years)	The WPAI assess the impact of IBD on work productivity and daily activities during the previous 7 days. The WPAI includes 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI generates four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Unemployed participants only answer questions related to employment status and activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity
Mean Impairment while Working by WPAI in CD or UC Participants	From initial diagnosis until date of data collection (approximately 1 years)	The WPAI assess the impact of IBD on work productivity and daily activities during the previous 7 days. The WPAI includes 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI generates four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Unemployed participants only answer questions related to employment status and activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity
Mean Work Time Missed by WPAI in CD or UC Participants	From initial diagnosis until date of data collection (approximately 1 years)	The WPAI assess the impact of IBD on work productivity and daily activities during the previous 7 days. The WPAI includes 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI generates four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Unemployed participants only answer questions related to employment status and activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity.
Mean Total Activity Impairment by WPAI in CD or UC Participants	From initial diagnosis until date of data collection (approximately 1 years)	The WPAI assess the impact of IBD on work productivity and daily activities during the previous 7 days. The WPAI includes 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI generates four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Unemployed participants only answer questions related to employment status and activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity.

Secondary Outcome Measures

Name	Time	Method
Mean Score of Crohn's and ulcerative colitis Questionnaire-8 (CUCQ-8) in CD or UC Participants	From initial diagnosis until date of data collection (approximately 1 years)	The investigator will estimate the disease specific quality of life in patients with ulcerative colitis or crohn disease, using validated questionnaires - Crohn's and ulcerative colitis Questionnaire-8 (CUCQ-8).; CUCQ-8 : total score is evaluated from 0 (greatest QoL) to 24 (poorest QoL) with each items scoring range from 0 to 3
Mean Score of and inflammatory Bowel Disease Disability Index (IBD-DI) in CD or UC Participants	From initial diagnosis until date of data collection (approximately 1 years)	The investigator will estimate the disability in patients with ulcerative colitis or crohn disease, using validated questionnaire inflammatory Bowel Disease Disability Index (IBD-DI) IBD-DI : Each item is rated at 1-5 and interpretated for disability at -80 (maximum degree of disability) to 22 (no disability).
Mean Score of Hospital Anxiety and Depression Scale (HADS) in CD or UC Participants	From initial diagnosis until date of data collection (approximately 1 years)	The investigators will evaluate the prevalence and severity of psychosocial distress (anxiety and depression disorder) using variable validated questionnaires that Hospital Anxiety and Depression Scale HADS : Scores are interpreted as 0-7: normal, 8-10: borderline, 11-21: significant and the higher score means the more significant psychosocial distress.
Mean Score of Patient Health Questionnaire-9 (PHQ-9) in CD or UC Participants	From initial diagnosis until date of data collection (approximately 1 years)	The investigators will evaluate the prevalence and severity of psychosocial distress (anxiety and depression disorder) using variable validated questionnaires that Patient Health Questionnaire-9 (PHQ-9).; PHQ-9 : 0-4: minimal, 5-9: mild,10-14: moderate,15-19: moderately severe, 20-27: Severe, and 10 points or more are interpreted as major depression.
Mean Score of Anxious thoughts and tendencies (AT&T) in CD or UC Participants	From initial diagnosis until date of data collection (approximately 1 years)	The investigators will evaluate the prevalence and severity of anxiety disorder using variable validated questionnaires that Anxious thoughts and tendencies (AT\&T).; AT\&T:Based on the degree of anxiety, the total score is calculated from 4 points to 60 points.The higher score means the more significant anxiety disorder.

Trial Locations

Locations (1)

Kyung Hee University Medical Center; 🇰🇷 Seoul, Korea, Republic of