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Comparison of Two Medication Adherence Strategies to Improve Asthma Treatment Adherence

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University of Pennsylvania

Status

Completed

Conditions

Asthma
Lung Diseases

Treatments

Behavioral: Problem Solving
Behavioral: Attention Control

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00115323
R01HL073932 (U.S. NIH Grant/Contract)
190

Details and patient eligibility

About

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.

Full 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.

Enrollment

397 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No 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:

    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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

397 participants in 2 patient groups

1
Active Comparator group
Description:
Problem solving intervention
Treatment:
Behavioral: Problem Solving
2
Active Comparator group
Description:
Attention control intervention
Treatment:
Behavioral: Attention Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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