Clinical trial NCT03565432: Sick Leave, Work Disability and Quality of Life in Korean Patients With Inflammatory Bowel Diseases
Official title: Sick Leave, Work Disability and Quality of Life in Korean Patients With Inflammatory Bowel Diseases : A Prospective Survey Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis
Keywords: work disability
quality of life
psychosocial distress
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 402
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with inflammatory bowel disease (Crohn disease and ulcerative colitis) at Kyung Hee University Hospital

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean Total Percentage of Work Impairment by Work Productivity and Activity Impairment Questionnaire (WPAI) in CD or UC Participants
timeFrame: From initial diagnosis until date of data collection (approximately 1 years)
measure: Mean Work Time Missed by WPAI in CD or UC Participants
timeFrame: From initial diagnosis until date of data collection (approximately 1 years)
measure: Mean Impairment while Working by WPAI in CD or UC Participants
timeFrame: From initial diagnosis until date of data collection (approximately 1 years)
measure: Mean Total Activity Impairment by WPAI in CD or UC Participants
timeFrame: From initial diagnosis until date of data collection (approximately 1 years)
Secondary outcomes:
measure: Mean Score of Crohn's and ulcerative colitis Questionnaire-8 (CUCQ-8) in CD or UC Participants
timeFrame: From initial diagnosis until date of data collection (approximately 1 years)
measure: Mean Score of and inflammatory Bowel Disease Disability Index (IBD-DI) in CD or UC Participants
timeFrame: From initial diagnosis until date of data collection (approximately 1 years)
measure: Mean Score of Hospital Anxiety and Depression Scale (HADS) in CD or UC Participants
timeFrame: From initial diagnosis until date of data collection (approximately 1 years)
measure: Mean Score of Patient Health Questionnaire-9 (PHQ-9) in CD or UC Participants
timeFrame: From initial diagnosis until date of data collection (approximately 1 years)
measure: Mean Score of Anxious thoughts and tendencies (AT&T) in CD or UC Participants
timeFrame: From initial diagnosis until date of data collection (approximately 1 years)
Other outcomes:
measure: Correlation between work disability, psychosocial distress and quality of life
timeFrame: From initial diagnosis until date of data collection (approximately 1 years)
measure: Predictors that cause a decrease in work productivity of patients with inflammatory bowel disease
timeFrame: From initial diagnosis until date of data collection (approximately 1 years)
measure: Mean Change From Baseline in Work Productivity and Activity Impairment (WPAI) under usual care at Year1
timeFrame: From initial diagnosis until date of data collection (approximately 1 years)
measure: Mean Change From Baseline in Crohn's and ulcerative colitis Questionnaire-8 (CUCQ-8) under usual care at Year1.
timeFrame: From initial diagnosis until date of data collection (approximately 1 years)
measure: Mean Change From Baseline in inflammatory Bowel Disease Disability Index (IBD-DI) under usual care at Year1.
timeFrame: From initial diagnosis until date of data collection (approximately 1 years)
measure: Mean Change From Baseline in Hospital Anxiety and Depression Scale (HADS) under usual care at Year1.
timeFrame: From initial diagnosis until date of data collection (approximately 1 years)
measure: Mean Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) under usual care at Year1
timeFrame: From initial diagnosis until date of data collection (approximately 1 years)
measure: Mean Change From Baseline in Anxious thoughts and tendencies (AT&T) under usual care at Year1
timeFrame: From initial diagnosis until date of data collection (approximately 1 years)
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical Center
Study officials:
affiliation: Kyunghee University Medical Center
name: Chang Kyun Lee, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.