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Enhancing Treatment Adherence in Pediatric Asthma With a Problem Solving Intervention

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tailored Problem Solving Intervention
Family Education Intervention
Sponsored by
Case Western Reserve University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Case Western Reserve University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental: Tailored Problem Solving Intervention

Control: Family Education Intervention

Arm Description

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

Participants will be randomized to follow a family education intervention.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
September 6, 2005
Last Updated
September 15, 2022
Sponsor
Case Western Reserve University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00149487
Brief Title
Enhancing Treatment Adherence in Pediatric Asthma With a Problem Solving Intervention
Official Title
Randomized Controlled Trial of Problem Solving Intervention to Enhance Treatment Adherence in Pediatric Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
January 22, 2001 (Actual)
Primary Completion Date
July 2, 2002 (Actual)
Study Completion Date
July 31, 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Western Reserve University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Examination of the efficacy of a tailored problem-solving intervention compared with family-based education in improving adherence to treatment regimens for children diagnosed as having asthma and their caregivers
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Tailored Problem Solving Intervention
Arm Type
Experimental
Arm Description
Participants will be randomized to follow a tailored problem solving intervention for the child.
Arm Title
Control: Family Education Intervention
Arm Type
Active Comparator
Arm Description
Participants will be randomized to follow a family education intervention.
Intervention Type
Behavioral
Intervention Name(s)
Tailored Problem Solving Intervention
Intervention Type
Behavioral
Intervention Name(s)
Family Education Intervention
Primary Outcome Measure Information:
Title
Adherence to medical treatment, based on electronic monitors
Description
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 Outcome Measure Information:
Title
Asthma-related morbidity, including symptoms, pulmonary functioning, and health-related quality of life
Description
test the relationship of treatment adherence to symptom control, quick-relief medication, and healthcare utilization.
Time Frame
3, 6, 9 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Drotar, PhD
Organizational Affiliation
Case Western Reserve University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

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Enhancing Treatment Adherence in Pediatric Asthma With a Problem Solving Intervention

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