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OpenTrials
Completed

NCT Number: NCT00115323

Comparison of Two Medication Adherence Strategies to Improve Asthma Treatment Adherence

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Problem Solving

Behavioral

Problem solving intervention

Attention Control

Behavioral

Attention control intervention

Primary outcomes

  1. Adherence to prescribed inhaled steroid regimen

    Time frame: Measured at Week 26

Secondary outcomes

  1. FEV1

    Time frame: Measured at Week 26

  2. Quality of life factors

    Time frame: Measured at Week 26

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Individualized Interventions to Improve Asthma Adherence

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Jun 22, 2005
Registry last updated
Dec 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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