NCT01783028

Brief Summary

This study tests the hypothesis that community health workers providing home visits to provide education and support for self-management of asthma, assessment of the home for environmental triggers, resources for asthma control, and assistance in effective communication with medical providers over the course of one year would reduce asthma morbidity, asthma-related urgent health care use and exposure to indoor asthma triggers among low income adults with not well controlled asthma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
366

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Mar 2008

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

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

March 1, 2008

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 4, 2013

Completed
Last Updated

May 12, 2014

Status Verified

May 1, 2014

Enrollment Period

3.7 years

First QC Date

January 31, 2013

Last Update Submit

May 8, 2014

Conditions

Keywords

asthma

Outcome Measures

Primary Outcomes (1)

  • asthma symptom-free days during the last two weeks

    Asthma symptoms are evaluated using the following questions: 1. During the past 14 days (that is, during the past fourteen 24 hour periods that include daytime and nighttime), on how many DAYS did you 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. During the DAYTIME in the past 14 days, how many DAYS did you have asthma symptoms, such as wheezing, cough, tightness in the chest, or shortness of breath? 3. During the past 14 days, how many days did you have to slow down or stop your usual activities because of asthma, wheezing or tightness in the chest, or cough? 4. During the NIGHTTIME in the past 14 nights, how many NIGHTS did you WAKE UP because of asthma, wheezing, cough, tightness in the chest, or shortness of breath?.

    baseline and 12 months after enrollment

Secondary Outcomes (1)

  • Asthma-related quality of life score during the last two weeks

    baseline and 12 months after enrollment

Other Outcomes (1)

  • health care utilization

    baseline and 12 months after enrollment

Study Arms (2)

Community Health Worker support

EXPERIMENTAL

home visits from community health workers providing education and support for self-management of asthma, assessment of the home for environmental triggers, resources for asthma control, and assistance in effective communication with medical providers

Behavioral: Community Health Worker support

the usual care control group

NO INTERVENTION

Usual care is defined as services received by participants in the absence of the intervention plus information about community resources that support asthma self-management (such as classes and support groups) and educational pamphlets

Interventions

For the intervention group, a trained Community Health Worker (CHW) provided education, support and service coordination through home visits. The CHW first made an in home assessment visit. At the assessment visit, the participant had the opportunity to ask questions and sign written consent. During this visit, the CHW assessed the participant's knowledge of asthma, current status of asthma control, challenges with controlling asthma, self-management practices and exposure to asthma triggers. After enrollment, the participant received up to four follow-up educational visits 0.5, 1.5, 3.5 and 7 months later. In addition to scheduled visits, the CHWs worked with their participants on an as-needed basis via telephone, email, or additional home visits.

Also known as: CHW intervention
Community Health Worker support

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • residence of King County Washington
  • household income below the 250% of the 2007 federal poverty level
  • had "not well controlled asthma" or "very poorly controlled asthma"

You may not qualify if:

  • speak a language other than English or Spanish
  • no permanent housing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Health - Seattle & King County

Seattle, Washington, 98104, United States

Location

Related Publications (1)

  • Krieger J, Song L, Philby M. Community health worker home visits for adults with uncontrolled asthma: the HomeBASE Trial randomized clinical trial. JAMA Intern Med. 2015 Jan;175(1):109-17. doi: 10.1001/jamainternmed.2014.6353.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • James Krieger, MD

    Public Health - Seattle and King County

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Chronic Disease and Injury Prevention

Study Record Dates

First Submitted

January 31, 2013

First Posted

February 4, 2013

Study Start

March 1, 2008

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

May 12, 2014

Record last verified: 2014-05

Locations