Comparison of Two Medication Adherence Strategies to Improve Asthma Treatment Adherence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00115323
Recruitment Status : Completed
First Posted : June 22, 2005
Last Update Posted : December 23, 2013
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Andrea Apter, University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Asthma Lung Diseases Behavioral: Problem Solving Behavioral: Attention Control Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 397 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Individualized Interventions to Improve Asthma Adherence
Study Start Date : May 2005
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Problem solving intervention
Behavioral: Problem Solving
Problem solving intervention
Active Comparator: 2
Attention control intervention
Behavioral: Attention Control
Attention control intervention

Primary Outcome Measures :
  1. Adherence to prescribed inhaled steroid regimen [ Time Frame: Measured at Week 26 ]

Secondary Outcome Measures :
  1. FEV1 [ Time Frame: Measured at Week 26 ]
  2. Quality of life factors [ Time Frame: Measured at Week 26 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

    1. FEV1pp AND less than 80% at the time of study entry or within the 3 years prior to study entry
    2. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00115323

United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Heart, Lung, and Blood Institute (NHLBI)
Study Chair: Andrea Apter University of Pennsylvania

Publications of Results:
Other Publications:
Responsible Party: Andrea Apter, Professor of Medicine, University of Pennsylvania Identifier: NCT00115323     History of Changes
Other Study ID Numbers: 190
R01HL073932 ( U.S. NIH Grant/Contract )
First Posted: June 22, 2005    Key Record Dates
Last Update Posted: December 23, 2013
Last Verified: December 2013

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