Enhancing Treatment Adherence in Pediatric Asthma With a Problem Solving Intervention

September 15, 2022 updated by: Case Western Reserve University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3, 6, 9 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma-related morbidity, including symptoms, pulmonary functioning, and health-related quality of life
Time Frame: 3, 6, 9 and 12 months
test the relationship of treatment adherence to symptom control, quick-relief medication, and healthcare utilization.
3, 6, 9 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Western Reserve University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Dennis Drotar, PhD, Case Western Reserve University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2001

Primary Completion (Actual)

July 2, 2002

Study Completion (Actual)

July 31, 2005

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Actual)

September 19, 2022

Last Update Submitted That Met QC Criteria

September 15, 2022

Last Verified

November 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 257
  • R01HL069547 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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