Asthma Clinical Trial
Official title:
Coping Peer Intervention for Adherence
Inner-city African American and Hispanic adolescents suffer from disproportionately high rates of emergency room visits and hospitalizations for acute exacerbations of asthma. This study proposes the use of a coping peer support intervention, enhanced by a technology-based platform that infuses peer support throughout adolescents' daily routines, to increase adherence to daily controller medications and ultimately reduce asthma exacerbation risk in this important population subgroup.
High rates of asthma morbidity and mortality among inner-city African American and Hispanic
adolescents demand urgent intervention. To address this disparity, the investigators have
designed a culturally sensitive intervention aimed at improving adherence to daily
controller medications for asthma, and ultimately reduce asthma exacerbation risk, that fits
easily into adolescents' chaotic lifestyles.
The proposed study is a behavioral randomized controlled trial that tests if a coping peer
intervention can increase adherence to asthma controller medications among urban African
American and Hispanic adolescents 11 to 16 years of age. To ensure the project's success,
the principal investigator has assembled a multi-disciplinary team of researchers, including
behavioral and social science experts. The Specific Aims propose to: (1) evaluate the impact
of a 10-week coping peer support intervention on adherence and knowledge, compared to an
attention control; (2) evaluate the ability of a 10-week coping peer support intervention to
achieve sustained post-treatment improvements in adherence and knowledge, compared to an
attention control; and (3) to develop estimates needed for the design of a subsequent R01
behavioral controlled trial testing the efficacy of this intervention to decrease risk of
asthma exacerbations. The study's primary outcome is adherence to daily asthma controller
medications, measured using an objective electronic monitor. Study participants will be
randomized to receive equal asthma supervision and music tracks plus either: (1) group
support, coping peer group problem solving, and peer delivered asthma messages (intervention
group); or (2) study team developed and recorded asthma health messages (attention control
group) between music tracks, on a portable MP3 player. The group support and coping peer
group problem solving consists of: putting subjects together in a small group to discuss
barriers to adherence and ways to overcome these barriers; then having group members record
messages to each other about overcoming barriers that will be played on their MP3 player,
between music tracks, during the course of their daily routines. This effectively brings the
coping peer support from the group into the course of the adolescents' day-to-day lives. The
investigators hypothesize that it is the ability of the MP3 player to facilitate ongoing
peer support that will be the basis for improved adherence. The long term goal is to apply
the data from this research to submit an R01 grant application to conduct a behavioral
randomized trial evaluating the effectiveness of this coping peer intervention to improve
adherence, and ultimately reduce asthma exacerbations, in urban African American and
Hispanic adolescents with asthma.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Health Services Research
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