Coping Peer Intervention for Adherence
2 other identifiers
interventional
107
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable asthma
Started Jul 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 23, 2010
CompletedFirst Posted
Study publicly available on registry
July 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedOctober 25, 2012
October 1, 2012
1.9 years
July 23, 2010
October 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
10 weeks
Secondary Outcomes (1)
Asthma Knowledge assessed using the ZAP Asthma Knowledge Instrument
10 weeks
Study Arms (2)
Attention Control Group
ACTIVE COMPARATOR1\) Doctor Asthma Messages delivered over a 10 week time period; 2) Asthma Supervision; and 3) Music Tracks.
Intervention Group
EXPERIMENTAL1\) 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.
Interventions
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.
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.
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.
A member of the study team meets individually with each participant at baseline to teach proper use of a peak flow meter and spacer.
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.
Eligibility Criteria
You may qualify if:
- Self-identify as African American or Hispanic
- years of age
- Have persistent asthma
- Be on a prescription daily inhaled steroid medication for asthma
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rush University Medical Centerlead
- GlaxoSmithKlinecollaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (1)
Rush University Medical Center
Chicago, Illinois, 60612, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giselle S Mosnaim, MD, MS
Rush University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 23, 2010
First Posted
July 26, 2010
Study Start
July 1, 2010
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
October 25, 2012
Record last verified: 2012-10