Comparison of Two Medication Adherence Strategies to Improve Asthma Treatment Adherence
Individualized Interventions to Improve Asthma Adherence
2 other identifiers
interventional
397
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable asthma
Started May 2005
Longer than P75 for not_applicable asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 21, 2005
CompletedFirst Posted
Study publicly available on registry
June 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedDecember 23, 2013
December 1, 2013
4.8 years
June 21, 2005
December 20, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Adherence to prescribed inhaled steroid regimen
Measured at Week 26
Secondary Outcomes (2)
FEV1
Measured at Week 26
Quality of life factors
Measured at Week 26
Study Arms (2)
1
ACTIVE COMPARATORProblem solving intervention
2
ACTIVE COMPARATORAttention control intervention
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Related Publications (6)
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.
PMID: 19395075BACKGROUNDApter 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.
PMID: 20816190BACKGROUNDApter 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.
PMID: 19217741BACKGROUNDApter 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.
PMID: 17092853BACKGROUNDApter 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.
PMID: 18830764BACKGROUNDApter 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.
PMID: 21704360RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Andrea Apter
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
June 21, 2005
First Posted
June 22, 2005
Study Start
May 1, 2005
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
December 23, 2013
Record last verified: 2013-12