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

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.

Study Overview

• Status: Unknown
• Conditions: Asthma

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 Type: Observational
• Enrollment (Anticipated): 1100

Contacts and Locations

Study Locations

• Germany
  • Baden-Wuerttemberg
    • Bammental, Baden-Wuerttemberg, Germany, 69245
      • Weinmann, Steffen, Dr.
    • Heidelberg, Baden-Wuerttemberg, Germany, 69115
      • Heidelberg Metasystems GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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	6 months

Collaborators and Investigators

• Sponsor: Heidelberg Metasystems GmbH
• Investigators: Principal Investigator: Thomas . Froehlich, Dr. Dr.med., Kaiserstrasse 11 A, D 69115 Heidelberg

Publications and helpful links

General 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 record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Anticipated): May 1, 2009
• Study Completion (Anticipated): August 1, 2009

Study Registration Dates

• First Submitted: November 8, 2007
• First Submitted That Met QC Criteria: November 9, 2007
• First Posted (Estimate): November 12, 2007

Study Record Updates

• Last Update Posted (Estimate): January 9, 2009
• Last Update Submitted That Met QC Criteria: January 8, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Keywords: Single arm observational retrospective and prospective study
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: S-299/2007