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School-based Approaches to Help Pre-teens Manage Asthma (DMSP)

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Open Airways Educational Intervention
Peer Asthma Action Educational Intervention
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

11 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Children identified for this research will be a sample of 6th grade students enrolled in 19 public middle schools in Detroit, Michigan who meet the following criteria: 1) attend a participating school, 2) be 11-12 years old at the time of entry into the study (enrolled in 6th grade) and 3) based on NAEPP guidelines (a) have a diagnosis of asthma and have active asthma symptoms and/or have received a prescription for asthma medications in the last year, or (b) report the presence of 3 of 5 non-exercise related asthma symptoms in the last year on five or more occasions, or (c) report two or more exercise related asthma symptoms in the past year on five or more occasions, or (d) have a severity classification of persistent disease (mild, moderate, severe) based on night time questions, and 4) have returned a signed parental consent form.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    No Intervention

    Arm Label

    Open Airways Educational Intervention

    Open Airways and Peer Asthma Action Intervention Education

    Control Arm

    Arm Description

    Children in this arm will receive the Open Airways educational program which is an evidenced based asthma educational program for children, developed by the investigator.

    Children in this arm will receive BOTH the Open Airways asthma education program and the Peer Asthma Action education program.

    Children in the Control Arm will be interviewed in person at baseline, 12 month and 24 months.

    Outcomes

    Primary Outcome Measures

    Health Care Use Data
    health care use will be self reported in the telephone interviews with parents at baseline, 12 months and 24 months.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 19, 2005
    Last Updated
    January 16, 2013
    Sponsor
    University of Michigan
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00217776
    Brief Title
    School-based Approaches to Help Pre-teens Manage Asthma
    Acronym
    DMSP
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2003 (undefined)
    Primary Completion Date
    January 2009 (Actual)
    Study Completion Date
    January 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Michigan
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    This random trial will deploy 2 interventions and a control group with eleven and twelve year old, low income, African American students in middle schools in Detroit, MI. The goals are to determine if 1) a self-management program focused on pre-teen capabilities designed for middle schools produces desired outcomes, and 2) if the program, enhanced by a peer component, improves upon outcomes. Outcomes of interest are symptom experience, quality of life, self-management, and school grades.
    Detailed Description
    BACKGROUND: To date, no data provide information on the effects of middle school based interventions for pre-teens with asthma or the advantages of an approach that recognizes the importance of peer influence on pre-teen's asthma behavior. Interventions to reach low income minority populations are particularly needed. DESIGN NARRATIVE: If only one primary outcome is to be specified, it would be asthma morbidity, as evident in asthma symptoms. Data to assess outcomes will be collected at baseline, and 12 and 24 months post program through parent interviews and student surveys. Additional primary outcomes listed in the protocol include: Asthma related quality of life, disease management behavior and academic performance. Secondary outcomes include: peer support, school attendance, physical activity, health care use, and smoking behavior.

    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
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1292 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Open Airways Educational Intervention
    Arm Type
    Active Comparator
    Arm Description
    Children in this arm will receive the Open Airways educational program which is an evidenced based asthma educational program for children, developed by the investigator.
    Arm Title
    Open Airways and Peer Asthma Action Intervention Education
    Arm Type
    Active Comparator
    Arm Description
    Children in this arm will receive BOTH the Open Airways asthma education program and the Peer Asthma Action education program.
    Arm Title
    Control Arm
    Arm Type
    No Intervention
    Arm Description
    Children in the Control Arm will be interviewed in person at baseline, 12 month and 24 months.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Open Airways Educational Intervention
    Other Intervention Name(s)
    A 6 week asthma educational self management program for middle school students.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Peer Asthma Action Educational Intervention
    Other Intervention Name(s)
    Peer Asthma Action Educational Intervention is a peer led training program for children in multiple grades teaching them about asthma and asthma management.
    Primary Outcome Measure Information:
    Title
    Health Care Use Data
    Description
    health care use will be self reported in the telephone interviews with parents at baseline, 12 months and 24 months.
    Time Frame
    At Baseline, 12 month and 24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    11 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Children identified for this research will be a sample of 6th grade students enrolled in 19 public middle schools in Detroit, Michigan who meet the following criteria: 1) attend a participating school, 2) be 11-12 years old at the time of entry into the study (enrolled in 6th grade) and 3) based on NAEPP guidelines (a) have a diagnosis of asthma and have active asthma symptoms and/or have received a prescription for asthma medications in the last year, or (b) report the presence of 3 of 5 non-exercise related asthma symptoms in the last year on five or more occasions, or (c) report two or more exercise related asthma symptoms in the past year on five or more occasions, or (d) have a severity classification of persistent disease (mild, moderate, severe) based on night time questions, and 4) have returned a signed parental consent form.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Noreen M. Clark, PhD
    Organizational Affiliation
    University of Michigan School of Public Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    School-based Approaches to Help Pre-teens Manage Asthma

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