Assessment of the Social Cost of Crohn's Disease: Economic and Quality of Life Aspects (Study P04560) (COSMO)
|ClinicalTrials.gov Identifier: NCT00723840|
Recruitment Status : Completed
First Posted : July 29, 2008
Results First Posted : April 29, 2011
Last Update Posted : July 30, 2015
|Condition or disease||Intervention/treatment|
|Inflammatory Bowel Disease Crohn's Disease||Other: Observational Studies: participants treated according to the real clinical practice.|
|Study Type :||Observational|
|Actual Enrollment :||245 participants|
|Official Title:||Assessment of the Social Cost of Crohn's Disease (COsto Sociale Della Malattia di CrOhn - COSMO): Economic and Quality of Life Aspects|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
Crohn's Disease Participants
Participants with Crohn's Disease for at least 6 months, who have a Crohn's Disease Activity Index (CDAI) score >= 150. The CDAI score evaluates Crohn's disease symptoms - a score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
These participants have active disease despite drug therapy.
Other: Observational Studies: participants treated according to the real clinical practice.
No intervention was administered to the participants specifically for the purpose this study. Participant could be on any drug therapy.
Other Name: Crohn's Disease Participants
- Cost of Illness in Participants With Crohn's Disease [ Time Frame: Baseline, 6, 12, and 18 months ]
Direct health care costs, non health care costs and costs for productivity loss were calculated by observation period in Crohn's Disease participants (in active phase) with a CDAI score >= 150.
Direct health care costs refer to the resources used to prevent and treat a disease. Indirect costs include expenses for a participant's (or their caregiver's) transport, home assistance or home nursing assistance. Costs for productivity loss include the participant's (or their caregiver's) productivity loss or time loss.
- EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Scores in Participants With Crohn's Disease [ Time Frame: Baseline, 6, 12, and 18 months ]
EQ-5D was calculated for the pharmacoeconomics analysis to evaluate quality of life (QoL) in participants in the active phase with Crohn's Disease and had a CDAI score >= 150.
EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.