Comparison of Two Medication Adherence Strategies to Improve Asthma Treatment Adherence

Not Applicable

Completed

• Conditions: Asthma; Lung Diseases
• Interventions: Behavioral: Problem Solving; Behavioral: Attention Control

• Registration Number: NCT00115323
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-06-21
• Study First Submitted QC: 2005-06-21
• Study First Posted: 2005-06-22
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-20
• Last Update Posted: 2013-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 397

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Problem Solving	Problem solving intervention
2	Attention Control	Attention control intervention

Primary Outcome Measures

Name	Time	Method
Adherence to prescribed inhaled steroid regimen	Measured at Week 26

Secondary Outcome Measures

Name	Time	Method
FEV1	Measured at Week 26
Quality of life factors	Measured at Week 26

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States