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A+ Asthma Early Intervention in Asthma Management

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
A+ Asthma early intervention program
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

3 Years - 4 Years (Child)All SexesDoes not accept healthy volunteers

Children aged 3 and 4 years who have asthma that is currently active

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 19, 2005
    Last Updated
    February 17, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00217906
    Brief Title
    A+ Asthma Early Intervention in Asthma Management
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1999 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    This project will evaluate the effectiveness of a Head Start-based early intervention for designed to improve asthma management skill and practices of parents, pre-school children and Head Start staff.
    Detailed Description
    BACKGROUND: While increased asthma morbidity and mortality have been observed across all ethnicities, results from several studies have found that asthma morbidity has increased disproportionately in low-income African American children. Elementary school-based asthma education programs have shown promise in improving asthma management, and reducing asthma morbidity in this high-risk population, however, the fastest growing asthma risk is associated with children young than six. By elementary age many parents and children with asthma have well-established patterns of inappropriate asthma management that may be difficult to change. To date, no research has examined the impact of early intervention for asthma management in low-income, high-risk children. DESIGN NARRATIVE: Head Start sites will be randomized to either a minimal intervention control group or the A+ Asthma early intervention program designed to educate and assist Head Start teachers and family service coordinators to: optimize classroom management of asthma, educate, facilitate and reinforce appropriate parental medical and behavioral management of asthma, and instruct, model and reinforce early asthma knowledge and age-appropriate skills for preschool age children. The primary outcome that the study was designed to evaluate Head Start absences/days enrolled, determined by review of Head Start attendance records. The secondary outcomes specified in the protocol are health care utilization (emergency department visits, hospitalizations, primary care visits), asthma symptoms (restricted activity, symptom-free days, day and nighttime symptoms), asthma medications, parents' asthma-related quality of life, and parent, child and teacher asthma knowledge and management practices. The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    A+ Asthma early intervention program

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    4 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Children aged 3 and 4 years who have asthma that is currently active
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cynthia Rand
    Organizational Affiliation
    Johns Hopkins University

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16081544
    Citation
    Paasche-Orlow MK, Riekert KA, Bilderback A, Chanmugam A, Hill P, Rand CS, Brancati FL, Krishnan JA. Tailored education may reduce health literacy disparities in asthma self-management. Am J Respir Crit Care Med. 2005 Oct 15;172(8):980-6. doi: 10.1164/rccm.200409-1291OC. Epub 2005 Aug 4.
    Results Reference
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    A+ Asthma Early Intervention in Asthma Management

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