- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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
Visão geral do estudo
Status
Condições
Descrição detalhada
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 de estudo
Inscrição (Antecipado)
Contactos e Locais
Locais de estudo
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Baden-Wuerttemberg
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Bammental, Baden-Wuerttemberg, Alemanha, 69245
- Weinmann, Steffen, Dr.
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Heidelberg, Baden-Wuerttemberg, Alemanha, 69115
- Heidelberg Metasystems GmbH
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / 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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
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
Prazo: 6 months
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6 months
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Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
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
Prazo: 6 months
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6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Thomas . Froehlich, Dr. Dr.med., Kaiserstrasse 11 A, D 69115 Heidelberg
Publicações e links úteis
Publicações Gerais
- 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- S-299/2007
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