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Completed

NCT Number: NCT02258308

CDC Medicaid Asthma Home Visit Project

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CHW intervention

Behavioral

Home education and support for asthma self management

Primary outcomes

  1. Asthma symptom free days

    Time frame: last 14 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?

  2. Caretaker quality of life

    Time frame: last week

    Juniper Mini Asthma Quality of Life Questionnaire

  3. Health care utilization for asthma

    Time frame: 12 months

    number of unscheduled clinic visits+emergency department visits+hospitalization for asthma

  4. cost analysis

    Time frame: 12 months

    costs associated with health care utilization for asthma

Secondary outcomes

  1. nights with asthma symptoms

    Time frame: 14 days

    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?

  2. days with activity limitation due to asthma

    Time frame: 14 days

    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.

  3. days used asthma rescue medicine

    Time frame: 14 days

    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?

  4. asthma episodes

    Time frame: 3 months

    During the past three months, about how many asthma episodes did your child have?

  5. asthma control level

    Time frame: 14 days

    (% with well controlled asthma and % with very poorly controlled asthma)

Sponsors and collaborators

Lead sponsor

Public Health - Seattle and King County

Other Gov

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

Medicaid Asthma Home Visit Project: Improving Health and Reducing Costs of Health Care for Children With Asthma

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 7, 2014
Registry last updated
Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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