Assessment of the Social Cost of Crohn's Disease: Economic and Quality of Life Aspects (Study P04560)

Study Overview
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Brief Summary
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This observational study will evaluate the social cost and quality of life of participants who have had Crohn's Disease for at least 6 months and have active disease despite drug therapy. Participants are followed for a total of 18 months.

Detailed Description
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Participants for this study will be enrolled from 25 gastroenterology sites, even spread across Italy. Each center will enroll between 10 and 40 participants each.

Official Title
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Assessment of the Social Cost of Crohn's Disease (COsto Sociale Della Malattia di CrOhn - COSMO): Economic and Quality of Life Aspects

Conditions
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Inflammatory Bowel Disease, Crohn's Disease

Intervention / Treatment
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* Other: Observational Studies: participants treated according to the real clinical practice.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: participant must: be between 18 and 70 years of age, have active Crohn's disease (CD) with CDAI score >= 150 (as per amended protocol) in spite of drug therapy, or active fistulizing disease, be diagnosed with CD for at least 6 months, sign the informed consent, be capable of understanding the study and replying to the questionnaires. Exclusion Criteria: Participants who are unreliable in filling out questionnaires, Participants with diseases which may interfere with the cost's of CD or its complications, Participants who are participating in a clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Crohn's Disease Participants<br>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.<br>* No intervention was administered to the participants specifically for the purpose this study. Participant could be on any drug therapy.<br>* Other names: Crohn's Disease Participants;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost of Illness in Participants With Crohn's Disease | 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. | Baseline, 6, 12, and 18 months | 
| EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Scores in Participants With Crohn's Disease | 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. | Baseline, 6, 12, and 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EuroQOL (EQ-5D)