In this randomized control trial, we will examine the efficacy of two home-based asthma interventions on rates of electronically monitored adherence to daily asthma controller medication. Participants will be randomly assigned to 1) Self-Management (SM; Standard Care Group), or 2) Motivational Interviewing plus Self-Management Training (MI+SM; Intervention Group). The duration of the intervention condition will be 5 home visits over 2 months. Follow-up measures will be collected from families at 3-, and 6-months post-randomization.

Condition	Intervention
Asthma	Behavior: Motivational Interviewing plus Self-Management

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

BACKGROUND:

Asthma-related morbidity and mortality are disproportionately high among low-income African-American children. The impact of this asthma burden is particularly great on very young children and their families, resulting in high rates of emergency department care, hospitalization, decreased quality of life, and the risk of fatal asthma. Our research and that of others suggests that the contributing factors to this high morbidity include under-use of asthma primary preventive care, sub-optimal medical management, and inappropriate asthma management behaviors.

DESIGN NARRATIVE:

The primary outcome that the study was designed to evaluate adherence with asthma controller therapy as measured by electronic medication monitoring.

Key secondary outcomes Asthma morbidity as measured by symptom-free days, ED utilization and hospitalization, and caregiver/adolescent quality of life. Mediator variables include motivation for change, self-efficacy, and outcomes expectancies.

Genders Eligible for Study:  Male

Criteria

Inclusion Criteria:

1. Age 10-15 years.
2. Resident of Baltimore City.
3. A discharge diagnosis of Asthma or Reactive Airway Disease (ICD- 10 493.X)
4. A current ED visit or hospitalization for asthma.

f) Prescribed a daily asthma controller medication (Inhaled Corticosteroid or Leukotriene Modifier) based on parent report and/or JHPED discharge summary.

Exclusion Criteria:

1. Plans to move outside of the Baltimore City area within the next year
2. Current participation in another asthma education study
3. Families unwilling or unable to participate
4. Families who were enrolled and participated in the pilot study.

Please refer to this study by ClinicalTrials.gov identifier  NCT00269282

Study ID Numbers:  321
Last Updated:  December 22, 2005
Record first received:  December 21, 2005
ClinicalTrials.gov Identifier:  NCT00269282
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10