Clinical trial NCT00233181: Adherence Intervention for Minority Children With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2005-10-05
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: 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.

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 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).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Cynthia Rand
References:
citation: Paasche-Orlow MK, Riekert KA, Bilderback A, Chanmugam A, Hill P, Rand CS, Brancati FL, Krishnan JA. Tailored education may reduce health literacy disparities in asthma self-management. Am J Respir Crit Care Med. 2005 Oct 15;172(8):980-6. doi: 10.1164/rccm.200409-1291OC. Epub 2005 Aug 4.
citation: Otsuki M, Eakin MN, Rand CS, Butz AM, Hsu VD, Zuckerman IH, Ogborn J, Bilderback A, Riekert KA. Adherence feedback to improve asthma outcomes among inner-city children: a randomized trial. Pediatrics. 2009 Dec;124(6):1513-21. doi: 10.1542/peds.2008-2961.