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Coping Peer Intervention for Adherence

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Status

Completed

Conditions

Asthma

Treatments

Behavioral: Coping Peer Asthma Messages
Behavioral: Music Tracks
Behavioral: Doctor Asthma Messages
Behavioral: Asthma Supervision
Behavioral: Coping Peer Support

Study type

Interventional

Funder types

Other
Industry
NIH

Identifiers

NCT01169883
09111001
1R21HL098812-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

107 patients

Sex

All

Ages

11 to 16 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

107 participants in 2 patient groups

Attention Control Group
Active Comparator group
Description:
1) Doctor Asthma Messages delivered over a 10 week time period; 2) Asthma Supervision; and 3) Music Tracks.
Treatment:
Behavioral: Asthma Supervision
Behavioral: Doctor Asthma Messages
Behavioral: Music Tracks
Intervention Group
Experimental group
Description:
1) Coping Peer Support delivered over a 10 week time period; 2) Coping Peer Asthma Messages delivered over a 10 week time period; 3) Asthma Supervision; and 4) Music Tracks.
Treatment:
Behavioral: Asthma Supervision
Behavioral: Coping Peer Support
Behavioral: Coping Peer Asthma Messages
Behavioral: Music Tracks

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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