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CompletedNCT00149487Updated Sep 19, 2022

Enhancing Treatment Adherence in Pediatric Asthma With a Problem Solving Intervention

An interventional study of Tailored Problem Solving Intervention and Family Education Intervention in Asthma, sponsored by Case Western Reserve University. Completed at 1 site in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-09-19.

Sponsored by Case Western Reserve University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 4 years 7 months after the study started (first participant enrolled Jan 2001, registered Sep 2005).
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
6 Years to 17 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Asthma

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03

In context

Asthma

4,010 studies on the registry are indexed under Asthma; 514 are open to participants now.

This study's enrollment of 120 is above the median of 83 across 2,814 interventional studies indexed under Asthma.

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Lead sponsor

Case Western Reserve University is the lead sponsor of 161 studies on the registry; 29 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Presence of a serious comorbid chronic condition
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Experimental: Tailored Problem Solving Intervention

    Participants will be randomized to follow a tailored problem solving intervention for the child.

    Behavioral: Tailored Problem Solving Intervention · Behavioral: Family Education Intervention

  • Active comparator
    Control: Family Education Intervention

    Participants will be randomized to follow a family education intervention.

    Behavioral: Tailored Problem Solving Intervention · Behavioral: Family Education Intervention

Interventions

  • BehavioralTailored Problem Solving Intervention
  • BehavioralFamily Education Intervention
06

What researchers measure

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

    Time frame: 3, 6, 9 and 12 months

Secondary outcomes

  1. 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.

    Time frame: 3, 6, 9 and 12 months

07

Study locations

1 site
  • Case Western Reserve University
    Cleveland, Ohio 44106, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00149487
Responsible party
Sponsor
First posted
Sep 8, 2005
Start date
Jan 22, 2001
Primary completion
Jul 2, 2002
Completion
Jul 31, 2005
Last update
Sep 19, 2022

Study contacts

Dennis Drotar, PhD
principal investigator · Case Western Reserve University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2006. You cannot join it, but the record below documents what was studied.

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