Adherence Intervention for Minority Children With Asthma

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00233181
First received: October 3, 2005
Last updated: December 21, 2005
Last verified: December 2005
  Purpose

To evaluate the effectiveness of a Head Start-based early intervention for designed to improve asthma management skill and practices of parents, pre-school children and Head Start staff.


Condition Intervention
Asthma
Behavioral: Home-based adherence monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:


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

Study Start Date: April 2000
Estimated Study Completion Date: March 2005
Detailed Description:

BACKGROUND:

While increased asthma morbidity and mortality have been observed across all ethnicities, results from several studies have found that asthma morbidity has increased disproportionately in low-income African American children. Elementary school-based asthma education programs have shown promise in improving asthma management, and reducing asthma morbidity in this high-risk population, however, the fastest growing asthma risk is associated with children young than six. By elementary age many parents and children with asthma have well-established patterns of inappropriate asthma management that may be difficult to change. To date, no research has examined the impact of early intervention for asthma management in low-income, high-risk children.

DESIGN NARRATIVE:

The primary outcome that the study was designed to evaluate medical record documented emergency care for asthma at the JHPED over the eighteen-month follow-up period.

The secondary outcomes Adherence with asthma therapy based on Medicaid pharmacy claims for asthma medications, other asthma health care (urgent and primary), self-reported medication adherence, barriers to health care, restricted activity, nighttime symptoms, asthma medications, self and family asthma management behaviors, asthma management self-efficacy, functional status, and quality of life.

  Eligibility

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  1. Age 2-12 years.
  2. A current diagnosis of asthma or reactive airway disease
  3. Resident of Baltimore City.
  4. Two or more ED visits at the JHPED for asthma in the past 12 months, or hospitalization for asthma at the JHPED in the past 12 months by parent report.
  5. Not currently participating in other research studies (participation in previous studies will be noted).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233181

Sponsors and Collaborators
Investigators
Investigator: Cynthia Rand Johns Hopkins University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00233181     History of Changes
Other Study ID Numbers: 298
Study First Received: October 3, 2005
Last Updated: December 21, 2005
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 October 19, 2014