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Comparison of Two Medication Adherence Strategies to Improve Asthma Treatment Adherence

Primary Purpose

Asthma, Lung Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Problem Solving
Attention Control
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Problem solving intervention

Attention control intervention

Outcomes

Primary Outcome Measures

Adherence to prescribed inhaled steroid regimen

Secondary Outcome Measures

FEV1
Quality of life factors

Full Information

First Posted
June 21, 2005
Last Updated
December 20, 2013
Sponsor
University of Pennsylvania
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00115323
Brief Title
Comparison of Two Medication Adherence Strategies to Improve Asthma Treatment Adherence
Official Title
Individualized Interventions to Improve Asthma Adherence
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Lung Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
397 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Problem solving intervention
Arm Title
2
Arm Type
Active Comparator
Arm Description
Attention control intervention
Intervention Type
Behavioral
Intervention Name(s)
Problem Solving
Intervention Description
Problem solving intervention
Intervention Type
Behavioral
Intervention Name(s)
Attention Control
Intervention Description
Attention control intervention
Primary Outcome Measure Information:
Title
Adherence to prescribed inhaled steroid regimen
Time Frame
Measured at Week 26
Secondary Outcome Measure Information:
Title
FEV1
Time Frame
Measured at Week 26
Title
Quality of life factors
Time Frame
Measured at Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Apter
Organizational Affiliation
University of Pennsylvania
Official's Role
Study Chair
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19395075
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.
Results Reference
background
PubMed Identifier
20816190
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.
Results Reference
background
PubMed Identifier
19217741
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.
Results Reference
background
PubMed Identifier
17092853
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.
Results Reference
background
PubMed Identifier
18830764
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.
Results Reference
background
PubMed Identifier
21704360
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.
Results Reference
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Comparison of Two Medication Adherence Strategies to Improve Asthma Treatment Adherence

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