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Coping Peer Intervention for Adherence

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Information provided by (Responsible Party):
Giselle Mosnaim, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01169883
First received: July 23, 2010
Last updated: October 23, 2012
Last verified: October 2012
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Coping Peer Intervention for Adherence

Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Objectively measured adherence to inhaled corticosteroids using an electronic dose counter, (Doser CT; Meditrac, Inc., Hudson, MA) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 107
Study Start Date: July 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Attention Control Group
1) Doctor Asthma Messages delivered over a 10 week time period; 2) Asthma Supervision; and 3) Music Tracks.
Behavioral: Doctor Asthma Messages
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.
Behavioral: Asthma Supervision
A member of the study team meets individually with each participant at baseline to teach proper use of a peak flow meter and spacer.
Behavioral: Music Tracks
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.
Experimental: Intervention Group
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.
Behavioral: Coping Peer Support
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.
Behavioral: Coping Peer Asthma Messages
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.
Behavioral: Asthma Supervision
A member of the study team meets individually with each participant at baseline to teach proper use of a peak flow meter and spacer.
Behavioral: Music Tracks
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.

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

Ages Eligible for Study:   11 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01169883

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
GlaxoSmithKline
Investigators
Principal Investigator: Giselle S Mosnaim, MD, MS Rush University Medical Center
  More Information

No publications provided

Responsible Party: Giselle Mosnaim, Principal Investigator, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01169883     History of Changes
Other Study ID Numbers: 09111001, 1R21HL098812-01A1
Study First Received: July 23, 2010
Last Updated: October 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rush University Medical Center:
adherence
asthma
pediatrics
behavioral intervention
inner city

ClinicalTrials.gov processed this record on November 25, 2014