Enhancing Treatment Adherence in Pediatric Asthma With a Problem Solving Intervention

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00149487
First received: September 6, 2005
Last updated: November 6, 2006
Last verified: November 2006
  Purpose

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.


Condition Intervention
Asthma
Behavioral: Tailored Problem Solving Intervention
Behavioral: Family Education Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Problem Solving Intervention to Enhance Treatment Adherence in Pediatric Asthma

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Adherence to medical treatment, based on electronic monitors (measured at Months 3, 6, 9, and 12)

Secondary Outcome Measures:
  • Asthma-related morbidity, including symptoms, pulmonary functioning, and health-related quality of life (measured at Months 3, 6, 9 and 12)

Estimated Enrollment: 120
Study Start Date: January 2001
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.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149487

Locations
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Investigators
Principal Investigator: Dennis Drotar, PhD Case Western Reserve University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00149487     History of Changes
Other Study ID Numbers: 257, R01 HL069547
Study First Received: September 6, 2005
Last Updated: November 6, 2006
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014