nderstanding the impact of Ulcerative Colitis and its associated disease burden on patients
- Conditions
- K51.9Ulcerative colitis, unspecified
- Registration Number
- DRKS00009858
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Overall, 1804 evaluable patients had =1 follow-up visit. Over 24 months, mean [SD] disease severity measured by P-SCCAI/SCCAI reduced significantly from 4.2 [3.6]/3.0 [3.0] to 2.4 [2.7]/1.3 [2.1] [p <0.0001]. Patient-/physician-assessed suffering, quantified by PRISM, reduced significantly over 24 months [p <0.0001]. P-SCCAI/SCCAI and patient-/physician-assessed PRISM showed strong pairwise correlations [rho =0.60, p <0.0001], although physicians consistently underestimated these disease severity and suffering measures compared with patients. Patient-assessed PRISM moderately correlated with other outcome measures, including SIBDQ, PHQ-9, P-SCCAI, and SCCAI (rho = =-0.38 [negative correlations] or =0.50 [positive correlations], p <0.0001).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1890
• Patients aged = 18 years who have been diagnosed with Ulcerative Colitis = 12 months prior to study inclusion
• Signed a patient authorization form to use and disclose personal health information
None
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • To evaluate Pictorial Representation of Illness and Self Measure (PRISM) as an assessment tool for perceived disease-associated suffering in UC patients, by assessing correlation with Short quality of life in inflammatory Bowel Disease Questionnaire (SIBDQ) and Patient Health Questionnaire (PHQ-9) (quality of life), according to geographical location and disease severity.
- Secondary Outcome Measures
Name Time Method • To describe the multi-faceted burden of disease in recently diagnosed Ulcerative Colitis patients.