Comparison of Two Medication Adherence Strategies to Improve Asthma Treatment Adherence

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Andrea Apter, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00115323
First received: June 21, 2005
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Asthma
Lung Diseases
Behavioral: Problem Solving
Behavioral: Attention Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Individualized Interventions to Improve Asthma Adherence

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Adherence to prescribed inhaled steroid regimen [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FEV1 [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: No ]
  • Quality of life factors [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: No ]

Enrollment: 397
Study Start Date: May 2005
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Problem solving intervention
Behavioral: Problem Solving
Problem solving intervention
Active Comparator: 2
Attention control intervention
Behavioral: Attention Control
Attention control intervention

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115323

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Study Chair: Andrea Apter University of Pennsylvania
  More Information

Publications:

Responsible Party: Andrea Apter, Professor of Medicine, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00115323     History of Changes
Other Study ID Numbers: 190, R01HL073932
Study First Received: June 21, 2005
Last Updated: December 20, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Asthma
Lung Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 29, 2014