Cobra (Severe Asthma)Medical-economic

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University Hospital, Montpellier
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01669681
First received: April 3, 2012
Last updated: April 3, 2013
Last verified: April 2013
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    • 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.


Estimated Enrollment: 130
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Included in the cohort COBRA
NO

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01669681

Contacts
Contact: Nicolas Molinari 04.67.33.89.79 nicolas.molinari@inserm.fr

Locations
France
Montpellier University Hospital Recruiting
Montpellier, France, 34090
Contact: Nicolas MOLINARI    04.67.33.89.79    nicolas.molinari@inserm.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Nicolas MOLINARI Montpellier University Hospital
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01669681     History of Changes
Other Study ID Numbers: UF 8871, 2011-A0156-35
Study First Received: April 3, 2012
Last Updated: April 3, 2013
Health Authority: France: Committee for the Protection of Personnes

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

ClinicalTrials.gov processed this record on September 18, 2014