Enhancing Treatment Adherence in Pediatric Asthma With a Problem Solving Intervention

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00149487
• Other study ID #: 257
• Secondary ID: R01HL069547
• Status: Completed
• Phase: N/A
• Start date: January 22, 2001
• Est. completion date: July 31, 2005

Study information

• Verified date: November 2006
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 31, 2005
• Est. primary completion date: July 2, 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Tailored Problem Solving Intervention

• Family Education Intervention

Locations

Country	Name	City	State
United States	Case Western Reserve University	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Western Reserve University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to medical treatment, based on electronic monitors	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	3, 6, 9 and 12 months
Secondary	Asthma-related morbidity, including symptoms, pulmonary functioning, and health-related quality of life	test the relationship of treatment adherence to symptom control, quick-relief medication, and healthcare utilization.	3, 6, 9 and 12 months