Comparison of Two Medication Adherence Strategies to Improve Asthma Treatment Adherence

Study Overview
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Brief Summary
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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
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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.

Official Title
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Individualized Interventions to Improve Asthma Adherence

Conditions
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Asthma, Lung Diseases

Intervention / Treatment
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* Behavioral: Problem Solving
* Behavioral: Attention Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Problem solving intervention | Behavioral: Problem Solving<br>* Problem solving intervention<br>|
| Active Comparator: 2<br>Attention control intervention | Behavioral: Attention Control<br>* Attention control intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to prescribed inhaled steroid regimen |  | Measured at Week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 |  | Measured at Week 26 | 
| Quality of life factors |  | Measured at Week 26 |