Increasing Adherence to Asthma Medication in Urban Teens

NCT00269282 | Completed DMC

• 2 other identifiers: 321R01HL079301
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Adherence to asthma controller therapy as measured by electronic medication monitoring

  Measured at baseline, 3 months, and 6 months

Secondary Outcomes (3)

• Number of symptom-free days

  Measured at baseline, 3 months, and 6 months

• Emergency department utilization and hospitalization

  Measured at baseline, 3 months, and 6 months

• Caregiver/adolescent quality of life

  Measured at baseline, 3 months, and 6 months

Study Arms (2)

1

ACTIVE COMPARATOR

Self-Management (SM) (Standard Care Group)

Behavioral: Self-Management Training

2

EXPERIMENTAL

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

Behavioral: Self-Management Training; Behavioral: Motivational Interviewing (MI)

Interventions

Self-Management Training BEHAVIORAL

Asthma education and self-monitoring strategies

1; 2

Motivational Interviewing (MI) BEHAVIORAL

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

2

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Johns Hopkins Hospital Pediatric Emergency Department

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Cynthia S. Rand, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Psychiatry/Director, The Johns Hopkins Adherence Research Center

Study Record Dates

• First Submitted: December 21, 2005
• First Posted: December 23, 2005
• Study Start: May 1, 2006
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: January 14, 2013

Record last verified: 2013-01

Locations

US (1)