Status:
COMPLETED
Comparison of Two Medication Adherence Strategies to Improve Asthma Treatment Adherence
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Asthma
Lung Diseases
Eligibility:
All Genders
18-90 years
Phase:
NA
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 adhe...
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 st...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
397 Patients enrolled
Trial Details
Trial ID
NCT00115323
Start Date
May 1 2005
End Date
March 1 2010
Last Update
December 23 2013
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104