Comparison of Two Medication Adherence Strategies to Improve Asthma Treatment Adherence

Asthma Clinical Trial

Official title:

Individualized Interventions to Improve Asthma Adherence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00115323
• Other study ID #: 190
• Secondary ID: R01HL073932
• Status: Completed
• Phase: N/A
• First received: June 21, 2005
• Last updated: December 20, 2013
• Start date: May 2005
• Est. completion date: March 2010

Study information

• Verified date: December 2013
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 397
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Lung Diseases

Intervention

Behavioral:
• Problem Solving
Problem solving intervention
• Attention Control
Attention control intervention

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (6)

Apter AJ, Cheng J, Small D, Bennett IM, Albert C, Fein DG, George M, Van Horne S. Asthma numeracy skill and health literacy. J Asthma. 2006 Nov;43(9):705-10. — View Citation

Apter AJ, Garcia LA, Boyd RC, Wang X, Bogen DK, Ten Have T. Exposure to community violence is associated with asthma hospitalizations and emergency department visits. J Allergy Clin Immunol. 2010 Sep;126(3):552-7. doi: 10.1016/j.jaci.2010.07.014. — View Citation

Apter AJ, Paasche-Orlow MK, Remillard JT, Bennett IM, Ben-Joseph EP, Batista RM, Hyde J, Rudd RE. Numeracy and communication with patients: they are counting on us. J Gen Intern Med. 2008 Dec;23(12):2117-24. doi: 10.1007/s11606-008-0803-x. Epub 2008 Oct 2. — View Citation

Apter AJ, Wang X, Bogen D, Bennett IM, Jennings RM, Garcia L, Sharpe T, Frazier C, Ten Have T. Linking numeracy and asthma-related quality of life. Patient Educ Couns. 2009 Jun;75(3):386-91. doi: 10.1016/j.pec.2009.01.003. Epub 2009 Feb 13. — View Citation

Apter AJ, Wang X, Bogen DK, Rand CS, McElligott S, Polsky D, Gonzalez R, Priolo C, Adam B, Geer S, Ten Have T. Problem solving to improve adherence and asthma outcomes in urban adults with moderate or severe asthma: a randomized controlled trial. J Allerg — View Citation

Naimi DR, Freedman TG, Ginsburg KR, Bogen D, Rand CS, Apter AJ. Adolescents and asthma: why bother with our meds? J Allergy Clin Immunol. 2009 Jun;123(6):1335-41. doi: 10.1016/j.jaci.2009.02.022. Epub 2009 Apr 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to prescribed inhaled steroid regimen		Measured at Week 26	No
Secondary	FEV1		Measured at Week 26	No
Secondary	Quality of life factors		Measured at Week 26	No