Increasing Adherence to Asthma Medication in Urban Teens
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Purpose
The purpose of this study is to determine the effectiveness of two home-based asthma interventions in increasing adherence to daily asthma controller medication.
| Condition | Intervention |
|---|---|
|
Asthma |
Behavioral: Self-Management Training Behavioral: Motivational Interviewing (MI) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Motivating Asthma Adherence in Urban Teens |
- 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 ]
- 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 ]
| Enrollment: | 207 |
| Study Start Date: | May 2006 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Self-Management (SM) (Standard Care Group)
|
Behavioral: Self-Management Training
Asthma education and self-monitoring strategies
|
|
Experimental: 2
Motivational Interviewing plus Self-Management Training (MI+SM)
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 10 Years to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Maryland | |
| Johns Hopkins Hospital Pediatric Emergency Department | |
| Baltimore, Maryland, United States, 21287 | |
| Principal Investigator: | Cynthia S. Rand, PhD | Johns Hopkins Medical Institutions |
More Information
No publications provided
| Responsible Party: | Cynthia Rand, Ph.D., Professor of Medicine and Psychiatry/Director, The Johns Hopkins Adherence Research Center, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00269282 History of Changes |
| Other Study ID Numbers: | 321, R01HL079301, R01 HL079301 |
| Study First Received: | December 21, 2005 |
| Last Updated: | January 11, 2013 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013