Coping Peer Intervention for Adherence
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coping Peer Support
Doctor Asthma Messages
Coping Peer Asthma Messages
Asthma Supervision
Music Tracks
Sponsored by

About this trial
This is an interventional health services research trial for Asthma focused on measuring adherence, asthma, pediatrics, behavioral intervention, inner city
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
Sites / Locations
- Rush University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Attention Control Group
Intervention Group
Arm Description
1) Doctor Asthma Messages delivered over a 10 week time period; 2) Asthma Supervision; and 3) Music Tracks.
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.
Outcomes
Primary Outcome Measures
Objectively measured adherence to inhaled corticosteroids using an electronic dose counter, (Doser CT; Meditrac, Inc., Hudson, MA)
Adherence is measured as the average of daily adherence to prescribed inhaled corticosteroid medication dose over 14 days at both baseline and at 10 weeks. The average rate of adherence in the intervention group at 10-weeks will be compared to that in the attention control group, adjusting for baseline levels, using a hierarchical linear model since participants are clustered into groups.
Secondary Outcome Measures
Asthma Knowledge assessed using the ZAP Asthma Knowledge Instrument
The average score on the ZAP Asthma Knowledge Instrument in the intervention group at 10-weeks will be compared to that in the attention control group, adjusting for baseline levels, using a hierarchical linear model since participants are clustered into groups.
Full Information
NCT ID
NCT01169883
First Posted
July 23, 2010
Last Updated
October 23, 2012
Sponsor
Rush University Medical Center
Collaborators
GlaxoSmithKline, National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT01169883
Brief Title
Coping Peer Intervention for Adherence
Official Title
Coping Peer Intervention for Adherence
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
Collaborators
GlaxoSmithKline, National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
adherence, asthma, pediatrics, behavioral intervention, inner city
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Attention Control Group
Arm Type
Active Comparator
Arm Description
1) Doctor Asthma Messages delivered over a 10 week time period; 2) Asthma Supervision; and 3) Music Tracks.
Arm Title
Intervention Group
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Coping Peer Support
Intervention Description
The Coping Peer Support is delivered at weekly group meetings over the 10 week active treatment phase. The Coping Peer Support consists of: group support, coping peer group problem solving, and development and recording of Coping Peer Asthma Messages. More specifically, a social worker facilitates a peer group discussion of barriers to taking their daily inhaled steroids, and ways to overcome these barriers. The social worker also facilitates peer recording of messages by the participants encouraging each other to take their daily inhaled steroid medication.
Intervention Type
Behavioral
Intervention Name(s)
Doctor Asthma Messages
Intervention Description
The attention control group will receive Doctor Asthma Messages delivered during the 10 week active treatment phase. The content and number of these messages will be equivalent to those received by the intervention group. These messages are developed and recorded by an Allergist/Immunologist. The participants in the attention control group will listen to these Doctor Asthma Messages, between their favorite music tracks on their MP3 player, as they go about their day-to-day activities.
Intervention Type
Behavioral
Intervention Name(s)
Coping Peer Asthma Messages
Intervention Description
The Coping Peer Asthma Messages developed and recorded by study participants for each other at the weekly coping peer group meetings will be placed on intervention group participants' MP3 players. These Coping Peer Asthma Messages will be played on their MP3 players, between their favorite music tracks, during the course of their daily routines. This infuses the coping peer support from the coping peer group meetings into the adolescents' daily routines.
Intervention Type
Behavioral
Intervention Name(s)
Asthma Supervision
Intervention Description
A member of the study team meets individually with each participant at baseline to teach proper use of a peak flow meter and spacer.
Intervention Type
Behavioral
Intervention Name(s)
Music Tracks
Intervention Description
Participants receive an MP3 player (iPod Shuffle) in the baseline period. Participants receives clean, radio-edited music tracks of their choice in the baseline period and 10 week active treatment period.
Primary Outcome Measure Information:
Title
Objectively measured adherence to inhaled corticosteroids using an electronic dose counter, (Doser CT; Meditrac, Inc., Hudson, MA)
Description
Adherence is measured as the average of daily adherence to prescribed inhaled corticosteroid medication dose over 14 days at both baseline and at 10 weeks. The average rate of adherence in the intervention group at 10-weeks will be compared to that in the attention control group, adjusting for baseline levels, using a hierarchical linear model since participants are clustered into groups.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Asthma Knowledge assessed using the ZAP Asthma Knowledge Instrument
Description
The average score on the ZAP Asthma Knowledge Instrument in the intervention group at 10-weeks will be compared to that in the attention control group, adjusting for baseline levels, using a hierarchical linear model since participants are clustered into groups.
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giselle S Mosnaim, MD, MS
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
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Coping Peer Intervention for Adherence
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