Estimating the Use of Resources and the Costs of Treating Patients With Asthma in the Autonomous Community of Valencia
| Tracking Information | |
|---|---|
| First Received Date ICMJE | April 20, 2010 |
| Last Updated Date | September 16, 2011 |
| Start Date ICMJE | September 2010 |
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
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 ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT01114906 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Estimating the Use of Resources and the Costs of Treating Patients With Asthma in the Autonomous Community of Valencia |
| Official Title ICMJE | Estimating the Use of Resources and the Costs of Treating Patients With Asthma in the Autonomous Community of Valencia |
| 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. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Time Perspective: Retrospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Probability Sample |
| Study Population | Ambulatory patients followed-up in Primary or Specialized Care Services (hospital) |
| Condition ICMJE |
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| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) | Not Provided |
| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 292 |
| Completion Date | June 2011 |
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 15 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Spain |
| Administrative Information | |
| NCT Number ICMJE | NCT01114906 |
| Other Study ID Numbers ICMJE | NIS-RES-DUM-2010/1 |
| Has Data Monitoring Committee | No |
| Responsible Party | AstraZeneca |
| Study Sponsor ICMJE | AstraZeneca |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | AstraZeneca |
| Verification Date | September 2011 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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