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Completed

NCT Number: NCT03565432

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

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.

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Key information

Conditions

Inflammatory Bowel Diseases Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Ulcerative Colitis

Sex eligibility

All sexes

Study type

Observational

Primary location

Kyung Hee University Medical Center

Seoul, 180-702, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

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

    Time frame: 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

  2. Mean Work Time Missed by WPAI in CD or UC Participants

    Time frame: 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.

  3. Mean Impairment while Working by WPAI in CD or UC Participants

    Time frame: 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

  4. Mean Total Activity Impairment by WPAI in CD or UC Participants

    Time frame: 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.

Secondary outcomes

  1. Mean Score of Crohn's and ulcerative colitis Questionnaire-8 (CUCQ-8) in CD or UC Participants

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

    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

  2. Mean Score of and inflammatory Bowel Disease Disability Index (IBD-DI) in CD or UC Participants

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

    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).

  3. Mean Score of Hospital Anxiety and Depression Scale (HADS) in CD or UC Participants

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

    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.

  4. Mean Score of Patient Health Questionnaire-9 (PHQ-9) in CD or UC Participants

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

    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.

  5. Mean Score of Anxious thoughts and tendencies (AT&T) in CD or UC Participants

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

    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.

Other outcomes

  1. Correlation between work disability, psychosocial distress and quality of life

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

    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.

  2. Predictors that cause a decrease in work productivity of patients with inflammatory bowel disease

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

    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.

  3. Mean Change From Baseline in Work Productivity and Activity Impairment (WPAI) under usual care at Year1

    Time frame: 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

  4. Mean Change From Baseline in Crohn's and ulcerative colitis Questionnaire-8 (CUCQ-8) under usual care at Year1.

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

    CUCQ-8 : total score is evaluated from 0 (greatest QoL) to 24 (poorest QoL) with each items scoring range from 0 to 3.

  5. Mean Change From Baseline in inflammatory Bowel Disease Disability Index (IBD-DI) under usual care at Year1.

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

    IBD-DI : Each item is rated at 1-5 and interpretated for disability at -80 (maximum degree of disability) to 22 (no disability).

  6. Mean Change From Baseline in Hospital Anxiety and Depression Scale (HADS) under usual care at Year1.

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

    HADS : Scores are interpreted as 0-7: normal, 8-10: borderline, 11-21: significant and the higher score means the more significant psychosocial distress.

  7. Mean Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) under usual care at Year1

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

    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.

  8. Mean Change From Baseline in Anxious thoughts and tendencies (AT&T) under usual care at Year1

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

    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.

Sponsors and collaborators

Lead sponsor

Kyunghee University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jun 21, 2018
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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