Clinical trial NCT00115323: Comparison of Two Medication Adherence Strategies to Improve Asthma Treatment Adherence
Official title: Individualized Interventions to Improve Asthma Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lung Diseases
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-06-22
Enrollment: 397
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence to prescribed inhaled steroid regimen
timeFrame: Measured at Week 26
Secondary outcomes:
measure: FEV1
timeFrame: Measured at Week 26
measure: Quality of life factors
timeFrame: Measured at Week 26
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Andrea Apter
role: STUDY_CHAIR
References:
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.
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.
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.
citation: 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. doi: 10.1080/02770900600925585.
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.
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 Allergy Clin Immunol. 2011 Sep;128(3):516-23.e1-5. doi: 10.1016/j.jaci.2011.05.010. Epub 2011 Jun 25.