- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00557141
Observational Study Regarding Adherence, Drug Use, Will to Take Part in Shared Decisioning in Asthma Outpatients
AsthmaCare Study Covering Adherence, Drug Use, Will to Take Part in Shared Decisioning in Asthma Outpatients
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Baden-Wuerttemberg
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Bammental, Baden-Wuerttemberg, Germania, 69245
- Weinmann, Steffen, Dr.
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Heidelberg, Baden-Wuerttemberg, Germania, 69115
- Heidelberg Metasystems GmbH
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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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
Lasso di tempo: 6 months
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6 months
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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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
Lasso di tempo: 6 months
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6 months
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Thomas . Froehlich, Dr. Dr.med., Kaiserstrasse 11 A, D 69115 Heidelberg
Pubblicazioni e link utili
Pubblicazioni generali
- 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
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- S-299/2007
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .