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Clinical Trials/NCT00115323
NCT00115323
Completed
Not Applicable

Individualized Interventions to Improve Asthma Adherence

University of Pennsylvania1 site in 1 country397 target enrollmentMay 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Asthma
Sponsor
University of Pennsylvania
Enrollment
397
Locations
1
Primary Endpoint
Adherence to prescribed inhaled steroid regimen
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

This is a randomized, controlled study that will compare two medication adherence strategies in adults with moderate or severe persistent asthma as a method for improving or maintaining treatment adherence.

Detailed Description

Low-income minority adults have excessively high rates of morbidity from asthma. Poor medication adherence has been documented in these individuals and contributes to the high morbidity level. This study will compare a Problem Solving intervention with an Attention Control intervention to improve and sustain asthma self-management in a clinical setting. This study will include strategies to address contextual factors related to adherence. Participants will be recruited from clinics that serve minority and low-income individuals.

Registry
clinicaltrials.gov
Start Date
May 2005
End Date
March 2010
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Andrea Apter

Professor of Medicine

University of Pennsylvania

Eligibility Criteria

Inclusion Criteria

  • Receiving treatment for asthma at one of the participating clinics
  • Moderate or severe persistent asthma according to the NHLBI Guidelines
  • Current use of prescribed inhaled corticosteroids
  • Evidence of reversible airflow obstruction, as indicated by the following two criteria:
  • FEV1pp AND less than 80% at the time of study entry or within the 3 years prior to study entry
  • An increase of greater than 15% and 200ml in FEV1 with asthma treatment over the last 3 years (if there is no record of such improvement, participants will be evaluated via spirometry pre- and post-bronchodilator at the first study visit. An increase in FEV1 or FVC greater than 12% and 200 ml in FEV1 30 minutes following albuterol administration will represent evidence of reversible airflow obstruction. If a spirometer is not immediately available, participants may be evaluated using a peak flow meter, which reports a PEF. A PEFpp less than 80% and an improvement of at least 60 L per minute after the administration of albuterol will represent evidence of reversible airflow obstruction)
  • Has a functional telephone or mobile phone

Exclusion Criteria

  • Significant lung or cardiac disease (other than hypertension)
  • Psychiatric illness, such as mania or schizophrenia, that may make it impossible to understand or carry out the Problem Solving intervention

Outcomes

Primary Outcomes

Adherence to prescribed inhaled steroid regimen

Time Frame: Measured at Week 26

Secondary Outcomes

  • FEV1(Measured at Week 26)
  • Quality of life factors(Measured at Week 26)

Study Sites (1)

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