Clinical trial NCT01169883: Coping Peer Intervention for Adherence
Official title: Coping Peer Intervention for Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: adherence
asthma
pediatrics
behavioral intervention
inner city
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2010-07-26
Enrollment: 107
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Self-identify as African American or Hispanic
* 11-16 years of age
* Have persistent asthma
* Be on a prescription daily inhaled steroid medication for asthma

Exclusion Criteria:

* Candidate refusal
* Presence of other co-morbidities that could interfere with study participation
* greater than 47% adherence to daily inhaled steroid medication as measured at baseline using the Doser CT

Primary outcomes:
measure: Objectively measured adherence to inhaled corticosteroids using an electronic dose counter, (Doser CT; Meditrac, Inc., Hudson, MA)
timeFrame: 10 weeks
Secondary outcomes:
measure: Asthma Knowledge assessed using the ZAP Asthma Knowledge Instrument
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Giselle S Mosnaim, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: