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
  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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269282

Locations
United States, Maryland
Johns Hopkins Hospital Pediatric Emergency Department
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Cynthia S. Rand, PhD Johns Hopkins University
  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
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 20, 2014