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

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.

Completed

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Key information

Conditions

Inflammatory Bowel Disease Crohn Disease Crohn's Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

Other names: Crohn's Disease Participants

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Acronym: COSMO

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2009
First posted: Jul 29, 2008
Registry last updated: Jul 30, 2015

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.

Published trials that share one or more normalized conditions with this study.

Completed