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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Heidelberg Metasystems GmbH.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Heidelberg Metasystems GmbH
ClinicalTrials.gov Identifier:
NCT00557141
First received: November 8, 2007
Last updated: January 8, 2009
Last verified: January 2009
  Purpose

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.


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: AsthmaCare Study Covering Adherence, Drug Use, Will to Take Part in Shared Decisioning in Asthma Outpatients

Further study details as provided by Heidelberg Metasystems GmbH:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1100
Study Start Date: January 2008
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557141

Locations
Germany
Weinmann, Steffen, Dr.
Bammental, Baden-Wuerttemberg, Germany, 69245
Heidelberg Metasystems GmbH
Heidelberg, Baden-Wuerttemberg, Germany, 69115
Sponsors and Collaborators
Heidelberg Metasystems GmbH
Investigators
Principal Investigator: Thomas . Froehlich, Dr. Dr.med. Kaiserstrasse 11 A, D 69115 Heidelberg
  More Information

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

Responsible Party: Dr. Dr. Thomas Froehlich, Heidelberg Metasystems GmbH
ClinicalTrials.gov Identifier: NCT00557141     History of Changes
Other Study ID Numbers: S-299/2007
Study First Received: November 8, 2007
Last Updated: January 8, 2009
Health Authority: Germany: Regierungspraesidium Karlsruhe, Abteilung 2

Keywords provided by Heidelberg Metasystems GmbH:
Single arm observational retrospective and prospective study

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 27, 2014