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Adherence Intervention for Minority Children With Asthma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00233181
First Posted: October 5, 2005
Last Update Posted: February 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  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

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

Study Start Date: April 2000
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.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00233181


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Cynthia Rand Johns Hopkins University
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00233181     History of Changes
Other Study ID Numbers: 298
R01HL052013 ( U.S. NIH Grant/Contract )
First Submitted: October 3, 2005
First Posted: October 5, 2005
Last Update Posted: February 18, 2016
Last Verified: December 2005

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