Increasing Adherence to Asthma Medication in Urban Teens
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-Management Training
Motivational Interviewing (MI)
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
Inclusion Criteria: Resident of Baltimore City Diagnosis of asthma or reactive airway disease Current emergency department visit or hospitalization for asthma Prescribed a daily asthma controller medication Exclusion Criteria: Plans to move outside of the Baltimore City area within 1 year from study entry Current participation in another asthma education study Families unwilling or unable to participate Families who were enrolled and participated in the pilot study
Sites / Locations
- Johns Hopkins Hospital Pediatric Emergency Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Self-Management (SM) (Standard Care Group)
Motivational Interviewing plus Self-Management Training (MI+SM)
Outcomes
Primary Outcome Measures
Adherence to asthma controller therapy as measured by electronic medication monitoring
Secondary Outcome Measures
Number of symptom-free days
Emergency department utilization and hospitalization
Caregiver/adolescent quality of life
Full Information
NCT ID
NCT00269282
First Posted
December 21, 2005
Last Updated
January 11, 2013
Sponsor
Johns Hopkins University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00269282
Brief Title
Increasing Adherence to Asthma Medication in Urban Teens
Official Title
Motivating Asthma Adherence in Urban Teens
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the effectiveness of two home-based asthma interventions in increasing adherence to daily asthma controller medication.
Detailed Description
BACKGROUND:
Low-income, minority teenagers have disproportionately high rates of asthma morbidity, including excess risk of emergency department (ED) care, hospitalization, and death from asthma, compared to white adolescents. Research by this group and others has documented that non-adherence with asthma treatment regimens is common among high-risk, inner city families with asthma, and that this poor adherence with prescribed therapies plays a significant contributing role in asthma morbidity. Inner-city adolescents with asthma are at particular risk of non-adherence, yet this population remains understudied. While asthma self-management training has shown promise in achieving some improvement in adherence with asthma, there are few intervention studies explicitly targeting adolescents, particularly those in the inner-city. Urban children typically assume primary control over their asthma management during late childhood/early adolescence. At the same time, adolescents' efforts to achieve autonomy and peer-acceptance may result in increased health risk behaviors, including poor asthma self-management. Developmentally-appropriate asthma self-management interventions are needed that target the unique challenges of adolescence. Motivational Interviewing (MI) is a promising interventional approach that uses a client-centered, non-directive approach for enhancing motivation to change health behaviors. MI techniques are developmentally consistent with the needs of early adolescents. MI does not assume that health will be the most important factor motivating the teen, but rather acknowledges and incorporates other motivators that are within the context of the teen's life, thus this intervention strategy has the flexibility to adapt to the unique life circumstances and stressors faced by urban adolescents. We propose to evaluate the relative effectiveness of a MI-focused self-management intervention (MI+SM) compared to a self-management (SM) intervention containing asthma education and self-monitoring strategies in a sample of 226 children age 10-15 years treated for asthma in the ED. Our primary hypothesis is that the MI+SM, as compared to SM alone, will result in greater improvement in medication adherence at 3- and 6-months post-randomization, as measured by electronic medication monitoring. Secondary outcomes include self-reported medication adherence, symptoms free days, urgent health care utilization for asthma, and caregiver/adolescent quality of life.
DESIGN NARRATIVE:
Participants will be randomly assigned to 1) Self-Management (SM; Standard Care Group) or 2) Motivational Interviewing plus Self-Management Training (MI+SM; Intervention Group). The duration of the intervention condition will be 5 home visits over 2 months. Follow-up measures will be collected from families at 3- and 6-months post-randomization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
207 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Self-Management (SM) (Standard Care Group)
Arm Title
2
Arm Type
Experimental
Arm Description
Motivational Interviewing plus Self-Management Training (MI+SM)
Intervention Type
Behavioral
Intervention Name(s)
Self-Management Training
Intervention Description
Asthma education and self-monitoring strategies
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing (MI)
Intervention Description
Motivational Interviewing (MI) is a promising interventional approach that uses a client-centered, non-directive approach for enhancing motivation to change health behaviors.
Primary Outcome Measure Information:
Title
Adherence to asthma controller therapy as measured by electronic medication monitoring
Time Frame
Measured at baseline, 3 months, and 6 months
Secondary Outcome Measure Information:
Title
Number of symptom-free days
Time Frame
Measured at baseline, 3 months, and 6 months
Title
Emergency department utilization and hospitalization
Time Frame
Measured at baseline, 3 months, and 6 months
Title
Caregiver/adolescent quality of life
Time Frame
Measured at baseline, 3 months, and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Resident of Baltimore City
Diagnosis of asthma or reactive airway disease
Current emergency department visit or hospitalization for asthma
Prescribed a daily asthma controller medication
Exclusion Criteria:
Plans to move outside of the Baltimore City area within 1 year from study entry
Current participation in another asthma education study
Families unwilling or unable to participate
Families who were enrolled and participated in the pilot study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia S. Rand, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital Pediatric Emergency Department
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
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Increasing Adherence to Asthma Medication in Urban Teens
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