Increasing Adherence to Asthma Medication in Urban Teens

NCT ID: NCT00269282

Last Updated: 2013-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2012-01-31

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Self-Management (SM) (Standard Care Group)

Group Type: ACTIVE_COMPARATOR

Self-Management Training

Intervention Type: BEHAVIORAL

Asthma education and self-monitoring strategies

2

Motivational Interviewing plus Self-Management Training (MI+SM)

Group Type: EXPERIMENTAL

Self-Management Training

Intervention Type: BEHAVIORAL

Asthma education and self-monitoring strategies

Motivational Interviewing (MI)

Intervention Type: BEHAVIORAL

Motivational Interviewing (MI) is a promising interventional approach that uses a client-centered, non-directive approach for enhancing motivation to change health behaviors.

Interventions

Self-Management Training

Asthma education and self-monitoring strategies

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Cynthia Rand, Ph.D.

Professor of Medicine and Psychiatry/Director, The Johns Hopkins Adherence Research Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cynthia S. Rand, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital Pediatric Emergency Department

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

R01HL079301

Identifier Type: NIH

Identifier Source: secondary_id

View Link

321

Identifier Type: -

Identifier Source: org_study_id