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Increasing Adherence to Asthma Medication in Urban Teens

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Cynthia Rand, Ph.D., Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00269282
First received: December 21, 2005
Last updated: January 11, 2013
Last verified: January 2013

December 21, 2005
January 11, 2013
May 2006
January 2012   (final data collection date for primary outcome measure)
Adherence to asthma controller therapy as measured by electronic medication monitoring [ Time Frame: Measured at baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00269282 on ClinicalTrials.gov Archive Site
  • Number of symptom-free days [ Time Frame: Measured at baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
  • Emergency department utilization and hospitalization [ Time Frame: Measured at baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
  • Caregiver/adolescent quality of life [ Time Frame: Measured at baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Increasing Adherence to Asthma Medication in Urban Teens
Motivating Asthma Adherence in Urban Teens

The purpose of this study is to determine the effectiveness of two home-based asthma interventions in increasing adherence to daily asthma controller medication.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Asthma
  • Behavioral: Self-Management Training
    Asthma education and self-monitoring strategies
  • Behavioral: Motivational Interviewing (MI)
    Motivational Interviewing (MI) is a promising interventional approach that uses a client-centered, non-directive approach for enhancing motivation to change health behaviors.
  • Active Comparator: 1
    Self-Management (SM) (Standard Care Group)
    Intervention: Behavioral: Self-Management Training
  • Experimental: 2
    Motivational Interviewing plus Self-Management Training (MI+SM)
    Interventions:
    • Behavioral: Self-Management Training
    • Behavioral: Motivational Interviewing (MI)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
207
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
10 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00269282
321, R01HL079301, R01 HL079301
Yes
Cynthia Rand, Ph.D., Johns Hopkins University
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Cynthia S. Rand, PhD Johns Hopkins University
Johns Hopkins University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP