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Completed

NCT Number: NCT00149487

Enhancing Treatment Adherence in Pediatric Asthma With a Problem Solving Intervention

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.

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Key information

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

About this study

BACKGROUND:

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.

DESIGN NARRATIVE:

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Tailored Problem Solving Intervention

Behavioral

Family Education Intervention

Behavioral

Primary outcomes

  1. Adherence to medical treatment, based on electronic monitors

    Time frame: 3, 6, 9 and 12 months

    describe the trajectories of adherence to daily inhaled corticosteroid (ICS) medication for a year in economically disadvantaged, African-American youth with asthma based on growth curve modeling

Secondary outcomes

  1. Asthma-related morbidity, including symptoms, pulmonary functioning, and health-related quality of life

    Time frame: 3, 6, 9 and 12 months

    test the relationship of treatment adherence to symptom control, quick-relief medication, and healthcare utilization.

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

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

Registry information

Official study title

Randomized Controlled Trial of Problem Solving Intervention to Enhance Treatment Adherence in Pediatric Asthma

Important dates

Study start
2001
Primary completion
2002
Study completion
2005
First posted
Sep 8, 2005
Registry last updated
Sep 19, 2022

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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