Estimating the Use of Resources and the Costs of Treating Patients With Asthma in the Autonomous Community of Valencia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01114906
First received: April 20, 2010
Last updated: September 16, 2011
Last verified: September 2011
  Purpose

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.


Condition
Asthma
Valencia Autonomous Region

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Estimating the Use of Resources and the Costs of Treating Patients With Asthma in the Autonomous Community of Valencia

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Direct and indirect Resource Use of Asthma patients in 12 months [ Time Frame: 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. ] [ Designated as safety issue: No ]

Enrollment: 292
Study Start Date: September 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Ambulatory patients followed-up in Primary or Specialized Care Services (hospital)

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.
  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: NCT01114906

Locations
Spain
Research Site
Alcoy, Alicante, Spain
Research Site
Vila-real, Castellón, Spain
Research Site
Xativa, Valencia, Spain
Research Site
Valencia, Spain
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01114906     History of Changes
Other Study ID Numbers: NIS-RES-DUM-2010/1
Study First Received: April 20, 2010
Last Updated: September 16, 2011
Health Authority: Spain: Ethics Committee

Keywords provided by AstraZeneca:
Asthma
Resource use

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 16, 2014