AsthmaNCT00557141
Observational Study Regarding Adherence, Drug Use, Will to Take Part in Shared Decisioning in Asthma Outpatients
An observational study of Asthma, run by Heidelberg Metasystems GmbH at 2 sites in Germany.
Trial summary
In a private practice setting typical for ambulatory medicine in Germany, asthma staging according to the GINA guidelines will be correlated with "real life" treatment and self management of adult outpatients suffering from asthma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 1,100 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2008to Aug 2009
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care outpatiens of private practices in Germany, Age > 18 years, Asthma with irregular or regular use of short acting beta-agonists and / or: Asthma treatment with inhaled steroids, Ability to understand the questionnaire
Who may be able to join
- Age > 18 years
- Asthma with irregular or regular use of short acting beta-agonists and/or:
- Asthma treatment with inhaled steroids
- Ability to understand the questionnaire
Who cannot join
- Age < 18 years
- Significant airway disease other than asthma
- Asthma treatment with fixed combination of inhaled steroids with long or short acting beta-agonists
- Ability to understand the questionnaire must be doubted
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Weinmann, Steffen, Dr.
Bammental, Baden-Wurttemberg, 69245
Heidelberg Metasystems GmbH
Heidelberg, Baden-Wurttemberg, 69115
About this study
Official title: AsthmaCare Study Covering Adherence, Drug Use, Will to Take Part in Shared Decisioning in Asthma Outpatients
In a private practice setting typical for ambulatory medicine in Germany, asthma staging according to the GINA guidelines will be correlated with "real life" treatment and self management of adult outpatients suffering from asthma. Attitudes concerning adherence, awareness, interest in shared decision making and knowledge about the disease are assessed.
Read the detailed description
The study focuses on outpatients that have two different types of treatment at hand: on-demand reliever treatment and anti-inflammatory treatment. We will assess the correlation of number of devices and medications in regular or intermittent use with doctors recommendations and prescriptions and the parameters adherence, awareness, interest in shared decision making and knowledge about the disease.
The patients will be seen two to three times. The first visit is used to inform the patient about the study, to check with regard to inclusion and exclusion criteria, and finally to sign the informed consent, if the patient agrees to be enrolled in the study. The patient then will get the questionnaire, and she or he is asked to collect all asthma related medications in continuous or intermittent use and to bring them to the private practice staff.
In the second visit, the private practice staff will check the medications the patient has brought. This is a physical check, i.e. it is based on devices and medications on the desk, not on questions.
At least six months later, the private practice staff will check all asthma related prescriptions for the patient concerned, and for the last six months. The patient will be asked to give information if the questionnaire has not been answered completely.
In a previous study with 1.670 paediatric outpatients enrolled we have shown under-diagnosis, under-treatment and a low overall effectiveness of paediatric outdoor patient asthma care. In this previous paediatric study we compared suspected diagnosis and reported treatment. We did not assess parameters indicating low or high adherence, nor did we ask for interest in shared decision making or for awareness and indicators for knowledge about the disease.
- Conditions
- Asthma
- Keywords
- Single arm observational retrospective and prospective study
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Age > 18 years, Asthma with irregular or regular use of short acting beta-agonists and / or: Asthma treatment with inhaled steroids, Ability to understand the questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of devices and packages of asthma medication in regular or intermittent individual use per asthma patient at time of enrollment and after an at least six months follow up period
Measured: 6 months
Secondary outcomes (1)
patients adherence,patients content with her / his health status and asthma treatment, patients awareness with regard to asthma treatment, interest in shared decision making, self-reported quality of life under asthma treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startJan 2008
- Primary completionMay 2009 (estimated)
- Study completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg Metasystems GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thomas . Froehlich, Dr. Dr.med., Principal investigator, Kaiserstrasse 11 A, D 69115 Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557141
- Sponsor's protocol ID
- S-299/2007
- Status last verified
- Jan 2009
- First submitted
- 8 Nov 2007
- Last updated
- 9 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Froehlich T, Henningsen P, Miall DS, Paetzold W, Ross A (2001) The Heidelberg Outdor Patient Asthma Study. XXthCongress of the European Academy of Allegology and Clinical Immunology, 9-13 May 2001, Berlin, Germany
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AsthmaCare Study Covering Adherence, Drug Use, Will to Take Part in Shared Decisioning in Asthma Outpatients
- ClinicalTrials.gov ID
- NCT00557141
- Acronym / sponsor ID
- S-299/2007
- Conditions
- Asthma
- Keywords
- Single arm observational retrospective and prospective study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Heidelberg Metasystems GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- May 2009 (estimated)
- Study completion
- Aug 2009 (estimated)
- First posted
- 12 Nov 2007 (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.
In a private practice setting typical for ambulatory medicine in Germany, asthma staging according to the GINA guidelines will be correlated with "real life" treatment and self management of adult outpatients suffering from asthma. Attitudes concerning adherence, awareness, interest in shared decision making and knowledge about the disease are assessed.
Detailed description
The study focuses on outpatients that have two different types of treatment at hand: on-demand reliever treatment and anti-inflammatory treatment. We will assess the correlation of number of devices and medications in regular or intermittent use with doctors recommendations and prescriptions and the parameters adherence, awareness, interest in shared decision making and knowledge about the disease.
The patients will be seen two to three times. The first visit is used to inform the patient about the study, to check with regard to inclusion and exclusion criteria, and finally to sign the informed consent, if the patient agrees to be enrolled in the study. The patient then will get the questionnaire, and she or he is asked to collect all asthma related medications in continuous or intermittent use and to bring them to the private practice staff.
In the second visit, the private practice staff will check the medications the patient has brought. This is a physical check, i.e. it is based on devices and medications on the desk, not on questions.
At least six months later, the private practice staff will check all asthma related prescriptions for the patient concerned, and for the last six months. The patient will be asked to give information if the questionnaire has not been answered completely.
In a previous study with 1.670 paediatric outpatients enrolled we have shown under-diagnosis, under-treatment and a low overall effectiveness of paediatric outdoor patient asthma care. In this previous paediatric study we compared suspected diagnosis and reported treatment. We did not assess parameters indicating low or high adherence, nor did we ask for interest in shared decision making or for awareness and indicators for knowledge about the disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Age > 18 years, Asthma with irregular or regular use of short acting beta-agonists and / or: Asthma treatment with inhaled steroids, Ability to understand the questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care outpatiens of private practices in Germany, Age > 18 years, Asthma with irregular or regular use of short acting beta-agonists and / or: Asthma treatment with inhaled steroids, Ability to understand the questionnaire
Key inclusion criteria (4 listed)
- Age > 18 years
- Asthma with irregular or regular use of short acting beta-agonists and/or:
- Asthma treatment with inhaled steroids
- Ability to understand the questionnaire
Key exclusion criteria (4 listed)
- Age < 18 years
- Significant airway disease other than asthma
- Asthma treatment with fixed combination of inhaled steroids with long or short acting beta-agonists
- Ability to understand the questionnaire must be doubted
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
Number of devices and packages of asthma medication in regular or intermittent individual use per asthma patient at time of enrollment and after an at least six months follow up period
Time frame: 6 months
1 secondary outcome
patients adherence,patients content with her / his health status and asthma treatment, patients awareness with regard to asthma treatment, interest in shared decision making, self-reported quality of life under asthma treatment
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2009.
- BackgroundFroehlich T, Henningsen P, Miall DS, Paetzold W, Ross A (2001) The Heidelberg Outdor Patient Asthma Study. XXthCongress of the European Academy of Allegology and Clinical Immunology, 9-13 May 2001, Berlin, Germany
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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.
Thomas . Froehlich, Dr. Dr.med. principal investigator
Kaiserstrasse 11 A, D 69115 Heidelberg
2 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, run by Heidelberg Metasystems GmbH at 2 sites in Germany.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
Results are not available in the source record.
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?
Number of devices and packages of asthma medication in regular or intermittent individual use per asthma patient at time of enrollment and after an at least six months follow up period (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00557141, which also lists 1 linked publication.
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 9 Jan 2009.