Randomized Controlled Trial of Problem Solving Intervention to Enhance Treatment Adherence in Pediatric Asthma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Adherence to medical treatment, based on electronic monitors
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 6 Years to 17 Years (Child)
- Sex
- 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
Arms & Interventions
Experimental: Tailored Problem Solving Intervention
Participants will be randomized to follow a tailored problem solving intervention for the child.
Intervention: Family Education Intervention (Behavioral)
Experimental: Tailored Problem Solving Intervention
Participants will be randomized to follow a tailored problem solving intervention for the child.
Intervention: Tailored Problem Solving Intervention (Behavioral)
Control: Family Education Intervention
Participants will be randomized to follow a family education intervention.
Intervention: Tailored Problem Solving Intervention (Behavioral)
Control: Family Education Intervention
Participants will be randomized to follow a family education intervention.
Intervention: Family Education Intervention (Behavioral)
Outcomes
Primary Outcomes
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
- Asthma-related morbidity, including symptoms, pulmonary functioning, and health-related quality of life(3, 6, 9 and 12 months)