Enhancing Treatment Adherence in Pediatric Asthma With a Problem Solving Intervention
NCT ID: NCT00149487
Last Updated: 2022-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2001-01-22
2005-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Experimental: Tailored Problem Solving Intervention
Participants will be randomized to follow a tailored problem solving intervention for the child.
Tailored Problem Solving Intervention
Family Education Intervention
Control: Family Education Intervention
Participants will be randomized to follow a family education intervention.
Tailored Problem Solving Intervention
Family Education Intervention
Interventions
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Tailored Problem Solving Intervention
Family Education Intervention
Eligibility Criteria
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Inclusion Criteria
* 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
6 Years
17 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Case Western Reserve University
OTHER
Responsible Party
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Principal Investigators
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Dennis Drotar, PhD
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University
Locations
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Case Western Reserve University
Cleveland, Ohio, United States
Countries
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Other Identifiers
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257
Identifier Type: -
Identifier Source: org_study_id
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