Clinical trial NCT00149487: Enhancing Treatment Adherence in Pediatric Asthma With a Problem Solving Intervention
Official title: Randomized Controlled Trial of Problem Solving Intervention to Enhance Treatment Adherence in Pediatric Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-09-08
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Examination of the efficacy of a tailored problem-solving intervention compared with family-based education in improving adherence to treatment regimens for children diagnosed as having asthma and their caregivers
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence to medical treatment, based on electronic monitors
timeFrame: 3, 6, 9 and 12 months
Secondary outcomes:
measure: Asthma-related morbidity, including symptoms, pulmonary functioning, and health-related quality of life
timeFrame: 3, 6, 9 and 12 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Dennis Drotar, PhD
role: PRINCIPAL_INVESTIGATOR
References: