Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-25 @ 7:17 PM
Study NCT ID:
NCT03565432
Status:
COMPLETED
Last Update Posted:
2020-09-02
First Post:
2018-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sick Leave, Work Disability and Quality of Life in Korean Patients With Inflammatory Bowel Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 402}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-31', 'studyFirstSubmitDate': '2018-04-25', 'studyFirstSubmitQcDate': '2018-06-11', 'lastUpdatePostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Correlation between work disability, psychosocial distress and quality of life', 'timeFrame': 'From initial diagnosis until date of data collection (approximately 1 years)', 'description': '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.'}, {'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)', 'description': '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.'}, {'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)', 'description': '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'}, {'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)', 'description': 'CUCQ-8 : total score is evaluated from 0 (greatest QoL) to 24 (poorest QoL) with each items scoring range from 0 to 3.'}, {'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)', 'description': 'IBD-DI : Each item is rated at 1-5 and interpretated for disability at -80 (maximum degree of disability) to 22 (no disability).'}, {'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)', 'description': 'HADS : Scores are interpreted as 0-7: normal, 8-10: borderline, 11-21: significant and the higher score means the more significant psychosocial distress.'}, {'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)', 'description': '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.'}, {'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)', 'description': '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.'}], 'primaryOutcomes': [{'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)', 'description': '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'}, {'measure': 'Mean Work Time Missed by WPAI in CD or UC Participants', 'timeFrame': 'From initial diagnosis until date of data collection (approximately 1 years)', 'description': '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.'}, {'measure': 'Mean Impairment while Working by WPAI in CD or UC Participants', 'timeFrame': 'From initial diagnosis until date of data collection (approximately 1 years)', 'description': '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'}, {'measure': 'Mean Total Activity Impairment by WPAI in CD or UC Participants', 'timeFrame': 'From initial diagnosis until date of data collection (approximately 1 years)', 'description': '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.'}], 'secondaryOutcomes': [{'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)', 'description': "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).\n\nCUCQ-8 : total score is evaluated from 0 (greatest QoL) to 24 (poorest QoL) with each items scoring range from 0 to 3"}, {'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)', 'description': '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).'}, {'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)', 'description': '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.'}, {'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)', 'description': '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).\n\nPHQ-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.'}, {'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)', 'description': 'The investigators will evaluate the prevalence and severity of anxiety disorder using variable validated questionnaires that Anxious thoughts and tendencies (AT\\&T).\n\nAT\\&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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['work disability', 'quality of life', 'psychosocial distress'], 'conditions': ['Inflammatory Bowel Diseases', 'Crohn Disease', 'Ulcerative Colitis']}, 'referencesModule': {'references': [{'pmid': '27340897', 'type': 'BACKGROUND', '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."}, {'pmid': '26164663', 'type': 'BACKGROUND', '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.'}, {'pmid': '23446333', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'Inflammatory bowel diseases (IBD) is a chronic inflammatory condition of the gastrointestinal tract that significantly affects quality of life of patients.\n\nSeveral 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.\n\nTherefore, 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.', 'detailedDescription': '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.\n\nSecondary, the predictor of work productivity impairment in patients with inflammatory bowel disease and distribution of type and severity of work disability will be identified.\n\nThird, the investigators will explore the correlation between the quality of life and psychosocial aspects (anxiety disorder, depression) of patients with inflammatory bowel disease.\n\nOne 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with inflammatory bowel disease (Crohn disease and ulcerative colitis) at Kyung Hee University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients diagnosed with inflammatory bowel disease (Crohn's disease and ulcerative colitis) at Kyung Hee University Hospital\n\nExclusion Criteria:\n\n1. Patients who do not agree to fill out the questionnaire.\n2. Patients who can not fill out the questionnaire themselves.\n3. Patients who can not understand the questionnaire."}, 'identificationModule': {'nctId': 'NCT03565432', 'briefTitle': 'Sick Leave, Work Disability and Quality of Life in Korean Patients With Inflammatory Bowel Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Kyunghee University Medical Center'}, 'officialTitle': 'Sick Leave, Work Disability and Quality of Life in Korean Patients With Inflammatory Bowel Diseases : A Prospective Survey Study', 'orgStudyIdInfo': {'id': 'IBDWORK2018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IBD in KHUH', 'description': 'Registered patients with Inflammatory bowel disease at Kyung Hee University Hospital'}]}, 'contactsLocationsModule': {'locations': [{'zip': '180-702', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyung Hee University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Chang Kyun Lee, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyunghee University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'After publishing the results, any data sharing request from other researchers will be positively considered.\n\nBut extent of sharing is not decided yet'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyunghee University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chang Kyun Lee', 'investigatorAffiliation': 'Kyunghee University Medical Center'}}}}