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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03565432
• Other study ID #: IBDWORK2018
• Status: Completed
• Start date: March 9, 2018
• Est. completion date: February 19, 2020

Study information

• Verified date: August 2020
• Source: Kyunghee University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: February 19, 2020
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kyunghee University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View Citation

Siebert U, Wurm J, Gothe RM, Arvandi M, Vavricka SR, von Känel R, Begré 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)