Enhancing Treatment Adherence in Pediatric Asthma With a Problem Solving Intervention
Randomized Controlled Trial of Problem Solving Intervention to Enhance Treatment Adherence in Pediatric Asthma
2 other identifiers
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable asthma
Started Jan 2001
Longer than P75 for not_applicable asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 22, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2005
CompletedFirst Submitted
Initial submission to the registry
September 6, 2005
CompletedFirst Posted
Study publicly available on registry
September 8, 2005
CompletedSeptember 19, 2022
November 1, 2006
1.4 years
September 6, 2005
September 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Asthma-related morbidity, including symptoms, pulmonary functioning, and health-related quality of life
3, 6, 9 and 12 months
Study Arms (2)
Experimental: Tailored Problem Solving Intervention
EXPERIMENTALParticipants will be randomized to follow a tailored problem solving intervention for the child.
Control: Family Education Intervention
ACTIVE COMPARATORParticipants will be randomized to follow a family education intervention.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Presence of a serious comorbid chronic condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Case Western Reserve University
Cleveland, Ohio, 44106, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dennis Drotar, PhD
Case Western Reserve University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2005
First Posted
September 8, 2005
Study Start
January 22, 2001
Primary Completion
July 2, 2002
Study Completion
July 31, 2005
Last Updated
September 19, 2022
Record last verified: 2006-11