AsthmaNCT02258308
CDC Medicaid Asthma Home Visit Project
A study testing CHW intervention in people with Asthma, run by Public Health - Seattle and King County.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- CHW intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 373 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
Official title: Medicaid Asthma Home Visit Project: Improving Health and Reducing Costs of Health Care for Children With Asthma
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- CHW intervention
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHW interventionBehavioural
Home education and support for asthma self management
| Study group | Role | What they receive |
|---|---|---|
| CHW intervention | Experimental | 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. Receives: Behavioral: CHW intervention |
| control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: last 14 days
Caretaker quality of life
Juniper Mini Asthma Quality of Life Questionnaire
Measured: last week
Health care utilization for asthma
number of unscheduled clinic visits+emergency department visits+hospitalization for asthma
Measured: 12 months
cost analysis
costs associated with health care utilization for asthma
Measured: 12 months
Secondary outcomes (5)
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?
Measured: 14 days
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.
Measured: 14 days
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?
Measured: 14 days
asthma episodes
During the past three months, about how many asthma episodes did your child have?
Measured: 3 months
asthma control level
(% with well controlled asthma and % with very poorly controlled asthma)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study startMay 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health - Seattle and King County
- Sponsor type
- Other government
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258308
- Sponsor's protocol ID
- PHSKC
- Status last verified
- Apr 2017
- First submitted
- 2 Oct 2014
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26270287
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medicaid Asthma Home Visit Project: Improving Health and Reducing Costs of Health Care for Children With Asthma
- ClinicalTrials.gov ID
- NCT02258308
- Acronym / sponsor ID
- PHSKC
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- Public Health - Seattle and King CountyOther government
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- May 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 7 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHW intervention | Experimental | Behavioral: CHW interventionThe 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. |
| control | No intervention | –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. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHW interventionHome education and support for asthma self management | Behavioural | CHW intervention |
Primary outcome
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?
Caretaker quality of life
Time frame: last week
Juniper Mini Asthma Quality of Life Questionnaire
Health care utilization for asthma
Time frame: 12 months
number of unscheduled clinic visits+emergency department visits+hospitalization for asthma
cost analysis
Time frame: 12 months
costs associated with health care utilization for asthma
5 secondary outcomes
nights with asthma symptoms
Time frame: 14 days
days with activity limitation due to asthma
Time frame: 14 days
days used asthma rescue medicine
Time frame: 14 days
asthma episodes
Time frame: 3 months
asthma control level
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- Results publication: PubMed 26270287Campbell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CHW intervention in people with Asthma, run by Public Health - Seattle and King County.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma symptom free days (time frame: last 14 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02258308, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.