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CDC Medicaid Asthma Home Visit Project

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CHW intervention
Sponsored by
Public Health - Seattle and King County
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma

Eligibility Criteria

3 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • caretaker is age 18 or older and child is age 3-17
  • have not controlled as thma
  • residence in King County
  • spoken language is English or Spanish
  • Child is enrolled in a Medicaid managed care health plan offered by Community Health Plan of Washington (CHPW) or Molina Health Plan of Washington, Inc (Molina).

Exclusion Criteria:

  • Parent/guardian plans to move out of King County within the next year or lacks permanent housing.
  • Parent/guardian has a mental or physical disability making it impossible to participate in the protocols.
  • The household appears to be unsafe for visitation by the CHW.
  • The child has other serious chronic medical conditions (e.g. poorly controlled sickle cell disease, cystic fibrosis) that cause sufficient limitation in functional status so that that asthma control is not a priority.
  • The family is enrolled in another asthma research study within the past three years. This is to avoid the potential confounding effect from other studies.
  • The child is in foster care or group care settings.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    CHW intervention

    control

    Arm Description

    The CHW intervention is in-home education and support by a community health worker (CHW). At the first home visit, the CHW assesses the participant's knowledge and skills related to asthma self-management, current status of the child's asthma, and resources and support for asthma self-management using a baseline questionnaire. The CHW will inspect the home environment using an Environmental Home Checklist to identify environmental triggers that can cause asthma symptoms and affect asthma control. The CHW makes up to three follow-up visits and two telephone visits during the year the participant is in the study. Participants receive resources to help them control asthma: vacuum cleaner, dust covers for a pillow and mattress and a "green" cleaning kit with cleaning supplies.

    The control group receives standard asthma care, as provided by a primary health care provider. When the intervention period is over, the control group receives one visit with a CHW and the resources provided to the intervention group participants.

    Outcomes

    Primary Outcome Measures

    Asthma symptom free days
    14 - During the past 14 days (that is, during the past fourteen 24 hour periods that include daytime and nighttime), on how many DAYS did your child have any asthma symptoms, such as wheezing, coughing, tightness in the chest, shortness of breath, waking up at night because of asthma symptoms, or slowing down of usual activities because of asthma?
    Caretaker quality of life
    Juniper Mini Asthma Quality of Life Questionnaire
    Health care utilization for asthma
    number of unscheduled clinic visits+emergency department visits+hospitalization for asthma
    cost analysis
    costs associated with health care utilization for asthma

    Secondary Outcome Measures

    nights with asthma symptoms
    During the nighttime in the past 14 nights, how many nights did your child wake up because of asthma symptoms such as wheezing, shortness of breath, or tightness in the chest, or cough?
    days with activity limitation due to asthma
    During the past 14 days, how many days did your child have to slow down or stop his/her play or usual activities or missed school because of asthma, wheezing or tightness in the chest, or cough.
    days used asthma rescue medicine
    During the past 14 days, about how many days did your child use asthma rescue medicine (sometimes called a quick relief medicine) such as albuterol, proventil, or ventolin?
    asthma episodes
    During the past three months, about how many asthma episodes did your child have?
    asthma control level
    (% with well controlled asthma and % with very poorly controlled asthma)

    Full Information

    First Posted
    October 2, 2014
    Last Updated
    April 12, 2017
    Sponsor
    Public Health - Seattle and King County
    Collaborators
    Centers for Disease Control and Prevention
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02258308
    Brief Title
    CDC Medicaid Asthma Home Visit Project
    Official Title
    Medicaid Asthma Home Visit Project: Improving Health and Reducing Costs of Health Care for Children With Asthma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2010 (undefined)
    Primary Completion Date
    October 2012 (Actual)
    Study Completion Date
    October 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Public Health - Seattle and King County
    Collaborators
    Centers for Disease Control and Prevention

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Asthmatic children age 3-17 from low income households in King County are randomly assigned into a community health worker (CHW) intervention group and a control group. The intervention is in-home education and support related to asthma self-management. The main outcome measures are asthma symptom-free days, caretaker's asthma-related quality of life score, and health care utilization for asthma measured at baseline and 12 months after baseline enrollment.
    Detailed Description
    This is a randomized controlled trial. Potentially eligible subjects come from lists generated by health plans (Community Health Plan of Washington and Molina, who insure the majority of Medicaid enrollees in King County), individuals referred by primary care providers, and self referral. Eligible subjects that agree to participate are randomly assigned into a CHW intervention group or a control group. We expected to complete the study with 200 in each group. The intervention is in-home education and support by a community health worker (CHW). At the first home visit, the CHW assesses the participant's knowledge and skills related to asthma self-management, current status of the child's asthma, and resources and support for asthma self-management using a baseline questionnaire. The CHW inspects the home environment using an Environmental Home Checklist to identify environmental triggers that can cause asthma symptoms and affect asthma control. The CHW makes up to three follow-up visits and two telephone visits during the year the participant is in the study. Participants receive resources to help them control asthma, including vacuum cleaner, dust covers for a pillow and mattress and a "green" cleaning kit with cleaning supplies. The control group receives standard asthma care, as provided by a primary health care provider during the 12 months after enrollment. When the intervention period is over, the control group receives one visit with a CHW and the resources provided to the intervention group participants. The main outcome variables include asthma symptom-free days, caretaker asthma-related quality of life, and urgent health care utilization.

    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
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    373 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CHW intervention
    Arm Type
    Experimental
    Arm Description
    The CHW intervention is in-home education and support by a community health worker (CHW). At the first home visit, the CHW assesses the participant's knowledge and skills related to asthma self-management, current status of the child's asthma, and resources and support for asthma self-management using a baseline questionnaire. The CHW will inspect the home environment using an Environmental Home Checklist to identify environmental triggers that can cause asthma symptoms and affect asthma control. The CHW makes up to three follow-up visits and two telephone visits during the year the participant is in the study. Participants receive resources to help them control asthma: vacuum cleaner, dust covers for a pillow and mattress and a "green" cleaning kit with cleaning supplies.
    Arm Title
    control
    Arm Type
    No Intervention
    Arm Description
    The control group receives standard asthma care, as provided by a primary health care provider. When the intervention period is over, the control group receives one visit with a CHW and the resources provided to the intervention group participants.
    Intervention Type
    Behavioral
    Intervention Name(s)
    CHW intervention
    Intervention Description
    Home education and support for asthma self management
    Primary Outcome Measure Information:
    Title
    Asthma symptom free days
    Description
    14 - During the past 14 days (that is, during the past fourteen 24 hour periods that include daytime and nighttime), on how many DAYS did your child have any asthma symptoms, such as wheezing, coughing, tightness in the chest, shortness of breath, waking up at night because of asthma symptoms, or slowing down of usual activities because of asthma?
    Time Frame
    last 14 days
    Title
    Caretaker quality of life
    Description
    Juniper Mini Asthma Quality of Life Questionnaire
    Time Frame
    last week
    Title
    Health care utilization for asthma
    Description
    number of unscheduled clinic visits+emergency department visits+hospitalization for asthma
    Time Frame
    12 months
    Title
    cost analysis
    Description
    costs associated with health care utilization for asthma
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    nights with asthma symptoms
    Description
    During the nighttime in the past 14 nights, how many nights did your child wake up because of asthma symptoms such as wheezing, shortness of breath, or tightness in the chest, or cough?
    Time Frame
    14 days
    Title
    days with activity limitation due to asthma
    Description
    During the past 14 days, how many days did your child have to slow down or stop his/her play or usual activities or missed school because of asthma, wheezing or tightness in the chest, or cough.
    Time Frame
    14 days
    Title
    days used asthma rescue medicine
    Description
    During the past 14 days, about how many days did your child use asthma rescue medicine (sometimes called a quick relief medicine) such as albuterol, proventil, or ventolin?
    Time Frame
    14 days
    Title
    asthma episodes
    Description
    During the past three months, about how many asthma episodes did your child have?
    Time Frame
    3 months
    Title
    asthma control level
    Description
    (% with well controlled asthma and % with very poorly controlled asthma)
    Time Frame
    14 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: caretaker is age 18 or older and child is age 3-17 have not controlled as thma residence in King County spoken language is English or Spanish Child is enrolled in a Medicaid managed care health plan offered by Community Health Plan of Washington (CHPW) or Molina Health Plan of Washington, Inc (Molina). Exclusion Criteria: Parent/guardian plans to move out of King County within the next year or lacks permanent housing. Parent/guardian has a mental or physical disability making it impossible to participate in the protocols. The household appears to be unsafe for visitation by the CHW. The child has other serious chronic medical conditions (e.g. poorly controlled sickle cell disease, cystic fibrosis) that cause sufficient limitation in functional status so that that asthma control is not a priority. The family is enrolled in another asthma research study within the past three years. This is to avoid the potential confounding effect from other studies. The child is in foster care or group care settings.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26270287
    Citation
    Campbell JD, Brooks M, Hosokawa P, Robinson J, Song L, Krieger J. Community Health Worker Home Visits for Medicaid-Enrolled Children With Asthma: Effects on Asthma Outcomes and Costs. Am J Public Health. 2015 Nov;105(11):2366-72. doi: 10.2105/AJPH.2015.302685. Epub 2015 Aug 13.
    Results Reference
    result

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    CDC Medicaid Asthma Home Visit Project

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