AsthmaNCT01114906
Estimating the Use of Resources and the Costs of Treating Patients With Asthma in the Autonomous Community of Valencia
An observational study of Asthma and Valencia Autonomous Region, run by AstraZeneca at 4 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Asthma, Valencia Autonomous Region
- How many people
- 292 participants
- Where
- 4 sitesSpain
- Study dates
- Sep 2010to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Ambulatory patients followed-up in Primary or Specialized Care Services (hospital)
Who may be able to join
- 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
Who cannot join
- Patients who have participated in a clinical trial in the last 12 months.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Research Site
Alcoy, Alicante
Research Site
Valencia, Valencia
Research Site
Vila-real, Castellón
Research Site
Xàtiva, Valencia
About this study
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.
- Conditions
- Asthma, Valencia Autonomous Region
- Keywords
- Asthma, Resource use
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Direct and indirect Resource Use of Asthma patients in 12 months
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01114906
- Sponsor's protocol ID
- NIS-RES-DUM-2010/1
- Status last verified
- Sep 2011
- First submitted
- 20 Apr 2010
- Last updated
- 19 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimating the Use of Resources and the Costs of Treating Patients With Asthma in the Autonomous Community of Valencia
- ClinicalTrials.gov ID
- NCT01114906
- Acronym / sponsor ID
- NIS-RES-DUM-2010/1
- Conditions
- Asthma, Valencia Autonomous Region
- Keywords
- Asthma, Resource use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 3 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Ambulatory patients followed-up in Primary or Specialized Care Services (hospital)
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who have participated in a clinical trial in the last 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Valencia Autonomous Region, run by AstraZeneca at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2011.