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Cobra (Severe Asthma)Medical-economic (Cobra)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01669681
First Posted: August 21, 2012
Last Update Posted: April 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Montpellier
  Purpose
The severe asthma is a major source of expenses in term of public health, while it concerns no more than 5 % of the asthmatics. The expenses is direct (medicines, hospitalizations, care) but especially indirect (absenteeisms, etc.). The forward-looking follow-up of cohort of more than 500 severe asthmatic patients multicentrique in an already widely established cohort (COBRA, at present in Visit 9 (one every 6 months) is an once-in-a-lifetime opportunity, coupled with the data of the CPAM, to identify well the evolution in time of a real medical economic variable. The possibility of dynamic follow-up of the expenses compared to the medical data offers perspectives of evaluation cost-efficiency of the informed therapeutic procedures. It is possible to couple in a forward-looking and dynamic way the data of health stemming from a cohort with the economic data stemming from the CPAM. This variable included in a Cluster's algorithm has to allow to identify the interventions the more and the less cost effective. The main objective of this study is to realize a cost estimate of care of the severe asthma. The variation of the costs will be also studied. The recruited patients are patients already included in the cohort COBRA in the centers of Marseille, Montpelier or Nice, classified GINA 4 and agreeing to participate.

Condition
Allergic Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Medical Economic Evaluation of the Care of the Severe Asthma : Cohort COBRA

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • 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 %).


Secondary Outcome Measures:
  • 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.


Enrollment: 81
Actual Study Start Date: December 20, 2011
Study Completion Date: December 16, 2016
Primary Completion Date: December 16, 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Included in the cohort COBRA

Detailed Description:

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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The recruited patients are patients already included in the observationnelle cohort COBRA in the centers of Marseille, Montpelier or Nice, classified GINA 4 and agreeing to participate.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
France
Montpellier University Hospital
Montpellier, France, 34090
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Nicolas MOLINARI Montpellier University Hospital
  More Information

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01669681     History of Changes
Other Study ID Numbers: 8871
2011-A0156-35 ( Registry Identifier: ID-RCB )
First Submitted: April 3, 2012
First Posted: August 21, 2012
Last Update Posted: April 7, 2017
Last Verified: March 2017

Keywords provided by University Hospital, Montpellier:
Severe asthma
Medical economic
care
Cost efficiency
CPAM
EQ5D

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases