Overview

This trial is active, not recruiting.

Condition asthma
Treatments tailored problem solving intervention, family education intervention
Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Start date January 2001
Trial size 120 participants
Trial identifier NCT00149487, 257, R01 HL069547

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Primary purpose treatment

Primary Outcomes

Measure
Adherence to medical treatment, based on electronic monitors (measured at Months 3, 6, 9, and 12)
time frame:

Secondary Outcomes

Measure
Asthma-related morbidity, including symptoms, pulmonary functioning, and health-related quality of life (measured at Months 3, 6, 9 and 12)
time frame:

Eligibility Criteria

Male or female participants from 6 years up to 17 years old.

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

Additional Information

Official title Randomized Controlled Trial of Problem Solving Intervention to Enhance Treatment Adherence in Pediatric Asthma
Principal investigator Dennis Drotar, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2006.
Information provided to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI).