NCT02258308

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
373

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started May 2010

Typical duration for not_applicable asthma

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 7, 2014

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

2.4 years

First QC Date

October 2, 2014

Last Update Submit

April 12, 2017

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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?

    last 14 days

  • Caretaker quality of life

    Juniper Mini Asthma Quality of Life Questionnaire

    last week

  • Health care utilization for asthma

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

    12 months

  • cost analysis

    costs associated with health care utilization for asthma

    12 months

Secondary Outcomes (5)

  • nights with asthma symptoms

    14 days

  • days with activity limitation due to asthma

    14 days

  • days used asthma rescue medicine

    14 days

  • asthma episodes

    3 months

  • asthma control level

    14 days

Study Arms (2)

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.

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.

Interventions

Home education and support for asthma self management

CHW intervention

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2014

First Posted

October 7, 2014

Study Start

May 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

April 13, 2017

Record last verified: 2017-04