- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02258308
CDC Medicaid Asthma Home Visit Project
Medicaid Asthma Home Visit Project: Improving Health and Reducing Costs of Health Care for Children With Asthma
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CHW intervention
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.
|
Home education and support for asthma self management
|
No Intervention: control
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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?
|
last 14 days
|
Caretaker quality of life
Time Frame: last week
|
Juniper Mini Asthma Quality of Life Questionnaire
|
last week
|
Health care utilization for asthma
Time Frame: 12 months
|
number of unscheduled clinic visits+emergency department visits+hospitalization for asthma
|
12 months
|
cost analysis
Time Frame: 12 months
|
costs associated with health care utilization for asthma
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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?
|
14 days
|
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.
|
14 days
|
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?
|
14 days
|
asthma episodes
Time Frame: 3 months
|
During the past three months, about how many asthma episodes did your child have?
|
3 months
|
asthma control level
Time Frame: 14 days
|
(% with well controlled asthma and % with very poorly controlled asthma)
|
14 days
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHSKC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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