Ignite Creation Date:
2024-05-05 @ 10:42 PM
Last Modification Date:
2024-10-26 @ 10:23 AM
Study NCT ID:
NCT01169883
Status:
COMPLETED
Last Update Posted:
2012-10-25
First Post:
2010-07-23
Brief Title:
Coping Peer Intervention for Adherence
Sponsor:
Rush University Medical Center
Organization:
Rush University Medical Center
Study Overview
Official Title:
Coping Peer Intervention for Adherence
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 projects 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 studys 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
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 projects 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 studys 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R21HL098812-01A1 | NIH | None | httpsreporternihgovquickSearch1R21HL098812-01A1 |