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

Sick Leave, Work Disability and Quality of Life in Korean Patients With Inflammatory Bowel Diseases : A Prospective Survey Study

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 402

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 180-702
    • Kyung Hee University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
IBD in KHUH; Registered patients with Inflammatory bowel disease at Kyung Hee University Hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Total Percentage of Work Impairment by Work Productivity and Activity Impairment Questionnaire (WPAI) in CD or UC Participants	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	From initial diagnosis until date of data collection (approximately 1 years)
Mean Work Time Missed by WPAI in CD or UC Participants	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.	From initial diagnosis until date of data collection (approximately 1 years)
Mean Impairment while Working by WPAI in CD or UC Participants	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	From initial diagnosis until date of data collection (approximately 1 years)
Mean Total Activity Impairment by WPAI in CD or UC Participants	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.	From initial diagnosis until date of data collection (approximately 1 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Score of Crohn's and ulcerative colitis Questionnaire-8 (CUCQ-8) in CD or UC Participants	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	From initial diagnosis until date of data collection (approximately 1 years)
Mean Score of and inflammatory Bowel Disease Disability Index (IBD-DI) in CD or UC Participants	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).	From initial diagnosis until date of data collection (approximately 1 years)
Mean Score of Hospital Anxiety and Depression Scale (HADS) in CD or UC Participants	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.	From initial diagnosis until date of data collection (approximately 1 years)
Mean Score of Patient Health Questionnaire-9 (PHQ-9) in CD or UC Participants	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.	From initial diagnosis until date of data collection (approximately 1 years)
Mean Score of Anxious thoughts and tendencies (AT&T) in CD or UC Participants	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.	From initial diagnosis until date of data collection (approximately 1 years)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between work disability, psychosocial distress and quality of life	Pearson coefficient analysis will be used to analyze the correlations between the results of each questionnaire (psychosocial distress, Quality of life and work disability) And two or three of outcomes with higher correlation efficient will be re-analyzed after adjustment of each variables.	From initial diagnosis until date of data collection (approximately 1 years)
Predictors that cause a decrease in work productivity of patients with inflammatory bowel disease	Predictors that may cause a decrease in work productivity of patients with inflammatory bowel disease will identified using linear regression analysis of multiple baseline variables and the score from Work productivity and Activity Index (WPAI) questionnaire.	From initial diagnosis until date of data collection (approximately 1 years)
Mean Change From Baseline in Work Productivity and Activity Impairment (WPAI) under usual care at Year1	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	From initial diagnosis until date of data collection (approximately 1 years)
Mean Change From Baseline in Crohn's and ulcerative colitis Questionnaire-8 (CUCQ-8) under usual care at Year1.	CUCQ-8 : total score is evaluated from 0 (greatest QoL) to 24 (poorest QoL) with each items scoring range from 0 to 3.	From initial diagnosis until date of data collection (approximately 1 years)
Mean Change From Baseline in inflammatory Bowel Disease Disability Index (IBD-DI) under usual care at Year1.	IBD-DI : Each item is rated at 1-5 and interpretated for disability at -80 (maximum degree of disability) to 22 (no disability).	From initial diagnosis until date of data collection (approximately 1 years)
Mean Change From Baseline in Hospital Anxiety and Depression Scale (HADS) under usual care at Year1.	HADS : Scores are interpreted as 0-7: normal, 8-10: borderline, 11-21: significant and the higher score means the more significant psychosocial distress.	From initial diagnosis until date of data collection (approximately 1 years)
Mean Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) under usual care at Year1	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.	From initial diagnosis until date of data collection (approximately 1 years)
Mean Change From Baseline in Anxious thoughts and tendencies (AT&T) under usual care at Year1	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.	From initial diagnosis until date of data collection (approximately 1 years)

Collaborators and Investigators

• Sponsor: Kyunghee University Medical Center
• Investigators: Principal Investigator: Chang Kyun Lee, Professor, Kyunghee University Medical Center

Publications and helpful links

General Publications

• De Boer AG, Bennebroek Evertsz' F, Stokkers PC, Bockting CL, Sanderman R, Hommes DW, Sprangers MA, Frings-Dresen MH. Employment status, difficulties at work and quality of life in inflammatory bowel disease patients. Eur J Gastroenterol Hepatol. 2016 Oct;28(10):1130-6. doi: 10.1097/MEG.0000000000000685.
• Vester-Andersen MK, Prosberg MV, Vind I, Andersson M, Jess T, Bendtsen F. Low Risk of Unemployment, Sick Leave, and Work Disability Among Patients with Inflammatory Bowel Disease: A 7-year Follow-up Study of a Danish Inception Cohort. Inflamm Bowel Dis. 2015 Oct;21(10):2296-303. doi: 10.1097/MIB.0000000000000493.
• Siebert U, Wurm J, Gothe RM, Arvandi M, Vavricka SR, von Kanel R, Begre S, Sulz MC, Meyenberger C, Sagmeister M; Swiss IBD Cohort Study Group. Predictors of temporary and permanent work disability in patients with inflammatory bowel disease: results of the swiss inflammatory bowel disease cohort study. Inflamm Bowel Dis. 2013 Mar-Apr;19(4):847-55. doi: 10.1097/MIB.0b013e31827f278e.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 9, 2018
• Primary Completion (ACTUAL): July 30, 2019
• Study Completion (ACTUAL): February 19, 2020

Study Registration Dates

• First Submitted: April 25, 2018
• First Submitted That Met QC Criteria: June 11, 2018
• First Posted (ACTUAL): June 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 2, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: quality of life; work disability; psychosocial distress
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases
• Other Study ID Numbers: IBDWORK2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

After publishing the results, any data sharing request from other researchers will be positively considered.

But extent of sharing is not decided yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No