NCT Number: NCT00233181
Adherence Intervention for Minority Children With Asthma
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.
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Conditions
Age range
2 year–12 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
- Age 2-12 years.
- A current diagnosis of asthma or reactive airway disease
- Resident of Baltimore City.
- 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.
- Not currently participating in other research studies (participation in previous studies will be noted).
Treatment and study plan
Sponsors and collaborators
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Nih
Registry information
Important dates
- Study start
- 2000
- Study completion
- 2005
- First posted
- Oct 5, 2005
- Registry last updated
- Feb 18, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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