Clinical trial NCT01114906: Estimating the Use of Resources and the Costs of Treating Patients With Asthma in the Autonomous Community of Valencia
Official title: Estimating the Use of Resources and the Costs of Treating Patients With Asthma in the Autonomous Community of Valencia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Valencia Autonomous Region
Keywords: Asthma
Resource use
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-05-03
Enrollment: 292
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Ambulatory patients followed-up in Primary or Specialized Care Services (hospital)

Brief summary: This study has been conceived in the context of Health Outcomes Research where the outcomes of health interventions in routine clinical practice constitute the main objective of the research process. In the case of asthma in Spain, the investigators do not clearly know the use of resources generated by the patient with asthma, its impact on the effectiveness of the current approach of asthmatic patients and the overall efficiency of health interventions on asthmatic patients. This observational, retrospective and multicenter study aims to estimate the use of health care resources in managing patients with asthma and to determine the management of the disease in the usual clinical practice in Valencia Autonomous Region. The data will be obtained at primary care level from the Electronic Health Record SIA+GAIA data base and at hospital level from allergologists and pneumologists clinical records. The investigators plan to introduce 289 ambulatory patients followed-up in Primary or Specialized Care Services, older than 15 years of age, diagnosed of asthma at least one year before the beginning of the study. The inclusion period will be of 3 months and the retrospective data of 12 previous months of follow-up will be collected.

The direct and indirect use of resources will be collected in order to estimate the management and use of health care resources in managing patients with asthma in the Autonomous region of Valencia as primary endpoint and also to estimate the mean cost of asthmatic patient healthcare; to determine the global effectiveness and the efficiency of the actual asthmatic patient healthcare and to model the health budget according to different objectives of effectiveness for the next five years.


Eligibility criteria: Inclusion Criteria:

* Ambulatory patients (Primary and Specialized Care)
* Patients with a diagnose of asthma in the Outpatients' Electronic Health Record \[Historia Clínica Ambulatoria electrónica (SIA + GAIA) database

Exclusion Criteria:

* Patients who have participated in a clinical trial in the last 12 months.

Primary outcomes:
measure: Direct and indirect Resource Use of Asthma patients in 12 months
timeFrame: Once the patient has been included data refered to the previous 12 month following-up period will be recorded. Thus, all data will be recorded at that time-period. Only one data recording will be done.
Secondary outcomes:
Other outcomes:
Locations:
city: Alcoy
country: Spain
facility: Research Site
state: Alicante
city: Vila-real
country: Spain
facility: Research Site
state: Castellón
city: Xativa
country: Spain
facility: Research Site
state: Valencia
city: Valencia
country: Spain
facility: Research Site
Study officials:
References: