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临床试验/NCT03565432
NCT03565432已完成不适用

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

Kyunghee University Medical Center1 个研究点 分布在 1 个国家目标入组 402 人开始时间: 2018年3月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
402
试验地点
1
主要终点
Mean Total Percentage of Work Impairment by Work Productivity and Activity Impairment Questionnaire (WPAI) in CD or UC Participants

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Mean Total Percentage of Work Impairment by Work Productivity and Activity Impairment Questionnaire (WPAI) in CD or UC Participants

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

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

Mean Impairment while Working by WPAI in CD or UC Participants

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

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

Mean Work Time Missed by WPAI in CD or UC Participants

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

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.

Mean Total Activity Impairment by WPAI in CD or UC Participants

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

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.

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chang Kyun Lee

Professor

Kyunghee University Medical Center

研究点 (1)

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