Observational Study Regarding Adherence, Drug Use, Will to Take Part in Shared Decisioning in Asthma Outpatients

NCT ID: NCT00557141

Last Updated: 2009-01-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-08-31

Brief 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. 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.

Conditions

Asthma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Heidelberg Metasystems GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Heidelberg Metasystems GmbH

Principal Investigators

Thomas . Froehlich, Dr. Dr.med.

Role: PRINCIPAL_INVESTIGATOR

Kaiserstrasse 11 A, D 69115 Heidelberg

Locations

Weinmann, Steffen, Dr.

Bammental, Baden-Wurttemberg, Germany

Heidelberg Metasystems GmbH

Heidelberg, Baden-Wurttemberg, Germany

Countries

Germany

References

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

Reference Type: BACKGROUND

Other Identifiers

S-299/2007

Identifier Type: -

Identifier Source: org_study_id