Enhancing Treatment Adherence in Pediatric Asthma With a Problem Solving Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00149487
Recruitment Status : Unknown
Verified November 2006 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was:  Active, not recruiting
First Posted : September 8, 2005
Last Update Posted : November 8, 2006
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary:
The purpose of this study is to determine the effectiveness of a tailored problem solving intervention in increasing adherence to asthma management behaviors in African American adolescents with asthma.

Condition or disease Intervention/treatment Phase
Asthma Behavioral: Tailored Problem Solving Intervention Behavioral: Family Education Intervention Not Applicable

Detailed Description:


Children and adolescents who are unable to adhere to their medical regimen for the management of chronic illness present considerable challenges to health care providers and researchers. Pediatric asthma is a chronic illness where the consequences of non-adherence are particularly detrimental and widespread, especially among economically disadvantaged minority children and their families. Studies of intervention of asthma management are needed for this population.


The aim of the proposed study is to test the efficacy of a problem solving intervention that is tailored to the observed adherence behaviors and identified barriers to increasing adherence in African American children and adolescents with asthma, and their families. Patients are randomized to either a Tailored Problem Solving Intervention, or a control group who will receive Family Education Intervention. Duration of the intervention is four months.

Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Problem Solving Intervention to Enhance Treatment Adherence in Pediatric Asthma
Study Start Date : January 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Primary Outcome Measures :
  1. Adherence to medical treatment, based on electronic monitors (measured at Months 3, 6, 9, and 12)

Secondary Outcome Measures :
  1. Asthma-related morbidity, including symptoms, pulmonary functioning, and health-related quality of life (measured at Months 3, 6, 9 and 12)

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • African American
  • Family income to be below the poverty line
  • Physician-based diagnosis of asthma of at least 12 months
  • Moderate to severe asthma (moderate asthma includes daily symptoms, daily use of inhaled short acting beta-agonist, exacerbations greater than 2 times per week that affect activity, and nighttime symptoms greater than once a week, FEV1 or Peak Flow PEF between 60 and 80 percent predicted and PEF variability greater than 30 percent; severe asthma includes continual symptoms, limited physical activity, frequent exacerbations together with frequent nighttime symptoms, FEV1 or PEF less than 60 percent predicted, and PEF variability greater than 30 percent)
  • Likely to be on a stable and daily medication (inhaled steroid) that can be modified electronically for the time period required to participate in the study

Exclusion Criteria:

  • Presence of a serious comorbid chronic condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00149487

United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Dennis Drotar, PhD Case Western Reserve University Identifier: NCT00149487     History of Changes
Other Study ID Numbers: 257
R01HL069547 ( U.S. NIH Grant/Contract )
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: November 8, 2006
Last Verified: November 2006

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