Comparison of Two Medication Adherence Strategies to Improve Asthma Treatment Adherence

December 20, 2013 updated by: Andrea Apter, University of Pennsylvania

Individualized Interventions to Improve Asthma 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

397

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Problem solving intervention
Behavioral: Problem Solving
Problem solving intervention
ACTIVE_COMPARATOR: 2
Attention control intervention
Behavioral: Attention Control
Attention control intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adherence to prescribed inhaled steroid regimen
Time Frame: Measured at Week 26
Measured at Week 26

Secondary Outcome Measures

Outcome Measure
Time Frame
FEV1
Time Frame: Measured at Week 26
Measured at Week 26
Quality of life factors
Time Frame: Measured at Week 26
Measured at Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Study Chair: Andrea Apter, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

March 1, 2010

Study Registration Dates

First Submitted

June 21, 2005

First Submitted That Met QC Criteria

June 21, 2005

First Posted (ESTIMATE)

June 22, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

December 23, 2013

Last Update Submitted That Met QC Criteria

December 20, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 190
  • R01HL073932 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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