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

Merck Sharp & Dohme LLC245 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

245

Conditions

Inflammatory Bowel Disease Crohn's Disease

Interventions

Observational Studies: participants treated according to the real clinical practice.OTHER

No intervention was administered to the participants specifically for the purpose this study. Participant could be on any drug therapy.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Baseline, 6, 12, and 18 months

Data from ClinicalTrials.gov

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