Asthma Clinical Trial
Official title:
Motivating Asthma Adherence in Urban Teens
The purpose of this study is to determine the effectiveness of two home-based asthma interventions in increasing adherence to daily asthma controller medication.
BACKGROUND:
Low-income, minority teenagers have disproportionately high rates of asthma morbidity,
including excess risk of emergency department (ED) care, hospitalization, and death from
asthma, compared to white adolescents. Research by this group and others has documented that
non-adherence with asthma treatment regimens is common among high-risk, inner city families
with asthma, and that this poor adherence with prescribed therapies plays a significant
contributing role in asthma morbidity. Inner-city adolescents with asthma are at particular
risk of non-adherence, yet this population remains understudied. While asthma
self-management training has shown promise in achieving some improvement in adherence with
asthma, there are few intervention studies explicitly targeting adolescents, particularly
those in the inner-city. Urban children typically assume primary control over their asthma
management during late childhood/early adolescence. At the same time, adolescents' efforts
to achieve autonomy and peer-acceptance may result in increased health risk behaviors,
including poor asthma self-management. Developmentally-appropriate asthma self-management
interventions are needed that target the unique challenges of adolescence. Motivational
Interviewing (MI) is a promising interventional approach that uses a client-centered,
non-directive approach for enhancing motivation to change health behaviors. MI techniques
are developmentally consistent with the needs of early adolescents. MI does not assume that
health will be the most important factor motivating the teen, but rather acknowledges and
incorporates other motivators that are within the context of the teen's life, thus this
intervention strategy has the flexibility to adapt to the unique life circumstances and
stressors faced by urban adolescents. We propose to evaluate the relative effectiveness of a
MI-focused self-management intervention (MI+SM) compared to a self-management (SM)
intervention containing asthma education and self-monitoring strategies in a sample of 226
children age 10-15 years treated for asthma in the ED. Our primary hypothesis is that the
MI+SM, as compared to SM alone, will result in greater improvement in medication adherence
at 3- and 6-months post-randomization, as measured by electronic medication monitoring.
Secondary outcomes include self-reported medication adherence, symptoms free days, urgent
health care utilization for asthma, and caregiver/adolescent quality of life.
DESIGN NARRATIVE:
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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