Home-Based Asthma Support and Education for Adults

Asthma Clinical Trial

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Official title:

Home-Based Asthma Support and Education for Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01783028
• Other study ID #: PHSKC-AST-HomeBASE
• Secondary ID: 1R01ES014583-01A
• Status: Completed
• Phase: N/A
• First received: January 31, 2013
• Last updated: May 8, 2014
• Start date: March 2008
• Est. completion date: November 2011

Study information

• Verified date: May 2014
• Source: Public Health - Seattle and King County
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

We used a randomized controlled parallel group design to compare the intervention to a usual-care control group. We attempted to evaluate the effectiveness of the intervention in the "real world," rather than its ideal efficacy.

The CHWs used protocols that specified education content, participant skill development and participant and CHW actions. The CHWs modified their approach to meet the priorities of participants using motivational interviewing techniques. They addressed asthma patho-physiology, reliever and controller medication use, self-monitoring, use of an asthma action plan, environmental assessment, trigger avoidance, effective use of the health care system, successful communication with health care providers, and weight control (obesity is associated with increased asthma symptoms). Participants also received low-literacy educational materials, in English or Spanish. The education concepts and environmental assessment activities were based on our prior healthy homes work modified for adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 366
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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"

Exclusion Criteria:

• speak a language other than English or Spanish

• no permanent housing

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Community Health Worker support
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.

Locations

Country	Name	City	State
United States	Public Health - Seattle & King County	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Public Health - Seattle and King County	National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	health care utilization	health care utilization includes asthma-related hospitalization, emergency department visit, and unscheduled clinic visit during the past 12 months	baseline and 12 months after enrollment	No
Primary	asthma symptom-free days during the last two weeks	Asthma symptoms are evaluated using the following questions: 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?; 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?; 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?; 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	No
Secondary	Asthma-related quality of life score during the last two weeks	Asthma Quality of Life Questionnaire; http://www.qoltech.co.uk/aqlq.html	baseline and 12 months after enrollment	No