Intervention for Improving Asthma Care for Minority Children in Head Start

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Cynthia Rand, Ph.D., Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00094276
First received: October 15, 2004
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

This study will evaluate two interventions that are designed to reduce asthma morbidity and improve asthma care of children in Head Start in urban Baltimore.


Condition Intervention Phase
Asthma
Lung Diseases
Behavioral: Facilitated Asthma Communication Intervention (FACI)
Behavioral: Breathmobile intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Improving Asthma Care for Minority Children in Head Start

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Symptom-free days [ Time Frame: Measured at baseline, 6 months and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health care utilization (i.e., emergency department visits, hospitalizations, and primary care visits) [ Time Frame: Measured at baseline, 6 months and 12 months ] [ Designated as safety issue: No ]
  • Asthma medications [ Time Frame: Measured at baseline, 6 months and 12 months ] [ Designated as safety issue: No ]
  • Parent asthma-related quality of life [ Time Frame: Measured at baseline, 6 months and 12 months ] [ Designated as safety issue: No ]
  • Parent asthma management practices [ Time Frame: Measured at baseline, 6 months and 12 months ] [ Designated as safety issue: No ]
  • Cost-effectiveness [ Time Frame: Measured at 12 months ] [ Designated as safety issue: No ]

Enrollment: 336
Study Start Date: September 2004
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Breathmobile intervention combined with a Facilitated Asthma Communication intervention (FACI)
Behavioral: Facilitated Asthma Communication Intervention (FACI)
A caregiver/PCP communication intervention designed to facilitate communication between parents and PCPs about a child's asthma severity and recommended therapy.
Behavioral: Breathmobile intervention
A community-based service that is specifically designed to deliver asthma screening and special consultation directly to families and children in high-risk neighborhoods.
Active Comparator: 2
FACI intervention
Behavioral: Facilitated Asthma Communication Intervention (FACI)
A caregiver/PCP communication intervention designed to facilitate communication between parents and PCPs about a child's asthma severity and recommended therapy.
Active Comparator: 3
Breathmobile intervention
Behavioral: Breathmobile intervention
A community-based service that is specifically designed to deliver asthma screening and special consultation directly to families and children in high-risk neighborhoods.
No Intervention: 4
Control group

Detailed Description:

BACKGROUND:

Asthma-related morbidity and mortality are disproportionately high among low-income African American children. The effects of asthma are particularly harsh in very young children and their families, resulting in high rates of emergency department care, hospitalization, decreased quality of life, and the risk of fatal asthma. Research suggests that the contributing factors to this high morbidity include under-use of asthma primary preventive care, sub-optimal medical management, and inappropriate asthma management behaviors. Despite the importance of early and regular asthma preventive care for children, this goal has proved elusive. Head Start programs offer an ideal venue for accessing high-risk, low-income preschool children and improving asthma morbidity. The study will test the hypothesis that removing barriers to preventive asthma care and facilitating communication between parents and primary care providers (PCP) are necessary prerequisites to optimally influence caregiver's asthma management practices. The study will remove barriers by the use of Breathmobile, a community-based service that is specifically designed to deliver asthma screening and special consultation directly to families and children in high-risk neighborhoods. In addition, the study will evaluate a caregiver/PCP communication intervention designed to facilitate communication between parents and PCPs about a child's asthma severity and recommended therapy.

DESIGN NARRATIVE:

This two times two modified factorial study design will compare the following in their effectiveness in reducing asthma morbidity and improving asthma management: a Breathmobile intervention combined with a Facilitated Asthma Communication intervention (FACI); a FACI alone; the Breathmobile intervention alone; or a control group. A total of 360 Head Start students ages 2 to 6 with symptomatic doctor-diagnosed asthma will be recruited. The primary study outcome measure will be the number of symptom-free days over a period of 12 months. Secondary outcomes include health care utilization (i.e., emergency department visits, hospitalizations, and primary care visits), asthma medications, parent asthma-related quality of life, parent asthma management practices, and cost-effectiveness. The study will test the hypothesis that a FACI combined with the Breathmobile intervention will be the most effective in improving parent and PCP management of the child's asthma and in reducing asthma morbidity.

  Eligibility

Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of asthma or reactive airway disease (RAD) OR
  • Experienced asthma symptoms within 1 month prior to study entry
  • Treated for asthma in the emergency department within 6 months prior to study entry
  • Asthma symptoms include day or nighttime wheezing, shortness of breath and cough, or use of rescue medicine (e.g., albuterol or ventolin)

Exclusion Criteria:

  • Currently participating in another asthma education research 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: NCT00094276

Locations
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Cynthia S. Rand 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: NCT00094276     History of Changes
Other Study ID Numbers: 168, R01HL073833-01, R01 HL73833
Study First Received: October 15, 2004
Last Updated: January 18, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Asthma
Lung Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on October 02, 2014