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

NCT03565432 | Completed

• 1 other identifier: IBDWORK2018
• Study Type: observational
• Target: 402
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Keywords

work disability; quality of life; psychosocial distress

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• 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)

Other Outcomes (8)

• Correlation between work disability, psychosocial distress and quality of life

  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

  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

  From initial diagnosis until date of data collection (approximately 1 years)

Study Arms (1)

IBD in KHUH

Registered patients with Inflammatory bowel disease at Kyung Hee University Hospital

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Patients who do not agree to fill out the questionnaire.
• Patients who can not fill out the questionnaire themselves.
• Patients who can not understand the questionnaire.

Sponsors & Collaborators

• Kyunghee University Medical Center: lead

Study Sites (1)

Kyung Hee University Medical Center

Seoul, 180-702, South Korea

Location

Related 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.

  PMID: 27340897 BACKGROUND

• 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.

  PMID: 26164663 BACKGROUND

• 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.

  PMID: 23446333 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Chang Kyun Lee, Professor

  Kyunghee University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: June 21, 2018
• Study Start: March 9, 2018
• Primary Completion: July 30, 2019
• Study Completion: February 19, 2020
• Last Updated: September 2, 2020

Record last verified: 2020-08

Locations

KR (1)