Cobra (Severe Asthma)Medical-economic (Cobra)
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ClinicalTrials.gov Identifier: NCT01669681 |
Recruitment Status :
Completed
First Posted : August 21, 2012
Last Update Posted : April 7, 2017
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Condition or disease |
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Allergic Asthma |
The following direct medical costs will be collected according to the point of view of the Social Security on a duration of 2 years:
- Hospitalizations (valuation from the GHS + medicines except GHS)· Consultations (valuation AM)
- Complementary(additional) examinations except hospitalization (valuation AM)
- Pharmacy (valuation AM)
- Transport (valuation AM)The estimate of average costs will be made with a reliable interval for 95 %.
The average cost by patient of the care will be calculated for every year of the follow-up. Relationship individual cost-efficiency: by analogy with the studies cost-efficiency comparative clauses, the investigators shall calculate a relationship cost-efficiency at the individual level as follows: (cost-year2 - cost-year1) / (efficiency-year2 - efficiency-year 1). Differences in these relationships will be looked for between various groups by tests of comparisons of averages.The construction of patients' clusters will be made according to the algorithm of the study SARP but also by using techniques statistics of classification non supervising to define our own algorithm. Variables used on our algorithm will include the relationship cost efficiency individual in addition to the clinical variables. The temporal stability of the relationship cost efficiency will be analyzed. The risk factors of a modification of this relationship will be looked for.
Study Type : | Observational |
Actual Enrollment : | 81 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Medical Economic Evaluation of the Care of the Severe Asthma : Cohort COBRA |
Actual Study Start Date : | December 20, 2011 |
Actual Primary Completion Date : | December 16, 2014 |
Actual Study Completion Date : | December 16, 2016 |
Group/Cohort |
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Included in the cohort COBRA |
- The costs will be updated at the rate recommended by the College of the Economists of the Health. For every year of follow-up will be calculated the individual costs and the annual average cost [ Time Frame: Baseline ]The costs will be updated at the rate recommended by the College of the Economists of the Health. For every year of follow-up will be calculated the individual costs and the annual average cost (with a reliable interval in 95 %).
- The clinical data will allow to measure the efficiency (control, exacerbation, hospitalization, composite score integrating these various variables). [ Time Frame: Baseline ]
- The clinical data will allow to measure the efficiency (control, exacerbation, hospitalization, composite score integrating these various variables).
- The relationship cost efficiency can so be calculated for two years for which we shall have the data.
- The utility will be measured by means of the validated questionnaire EQ 5D.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients included in the observationnal cohort COBRA for at least 6 months
- Patient members in one of the partner health insurance funds
Exclusion Criteria:
- The patient refusing his participation to the research
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669681
France | |
Montpellier University Hospital | |
Montpellier, France, 34090 |
Principal Investigator: | Nicolas MOLINARI | Montpellier University Hospital |
Responsible Party: | University Hospital, Montpellier |
ClinicalTrials.gov Identifier: | NCT01669681 |
Other Study ID Numbers: |
8871 2011-A0156-35 ( Registry Identifier: ID-RCB ) |
First Posted: | August 21, 2012 Key Record Dates |
Last Update Posted: | April 7, 2017 |
Last Verified: | March 2017 |
Severe asthma Medical economic care |
Cost efficiency CPAM EQ5D |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |