Clinical trial NCT04119271: Durham Healthy Breathing in Healthy Homes Project
Official title: Durham Healthy Breathing in Healthy Homes Project: A Duke-Reinvestment Partners Collaborative
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Poor Asthma Control
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Reinvestment Partners
First posted: 2019-10-08
Enrollment: 26
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To determine if Home-based Environmental Interventions (HEI) that improve home air-quality problems can improve asthma outcomes. Participants will benefit through home-based environmental interventions that improve home air-quality problems and improve asthma outcomes. All participants will receive a Breath Easy at Home Kit, which could help with reducing environmental exposures. The primary objective is to assess the feasibility and acceptability of the HEI measured by the proportion of families completing intervention components and proportion of caregivers expressing satisfaction with intervention components. Secondary objective is to explore the efficacy of a HEI on reducing environmental exposures measured using personal wristband monitors.

Exploratory objective is improvements in asthma control following HEI measured using asthma control scores and lung function. The fourth objection is to explore correlations between demographics, body weight, housing characteristics (smokers, electronic cigarette use, number of pets, housing type) with measures of acceptability, satisfaction and improved exposure markers.

Detailed description: The investigator propses a 23-week prospective, open label, single center, environmental remediation intervention study in 5-16 year old children with poor asthma control. At visit 1, wristbands will be dispensed and collected to estimate exposure to a suite of common organic contaminants including phthalates, organophosphate esters, several pesticides and polyaromatic hydrocarbons (PAH). During the initial home visit, the Healthy Homes Housing Specialist will conduct an environmental home assessment to identify asthma triggers in accordance with the EPA's recommendations for helping children with asthma. The Housing Specialist will follow the EPA document Home Characteristics and Asthma Triggers, and will provide the family with a Breathe Easy at Home Kit. The Specialist will provide training and instructions on how to use each of the supplies provided in the kit. If the Housing Specialist identifies necessary home repairs during the assessment process, the Housing Specialist can refer the family to organizations that offer home repairs, modifications, and weatherization services. The specialist will discuss the importance of clean air for maintaining lung health for all family members and will discuss the importance of banning of any indoor smoking, smoking anywhere around the household and smoking in any household automobiles (even when the child is not present). Follow up phone calls will be conducted to answer questions, complete questionnaires and complete a household environmental interview.

Eligibility criteria: Inclusion Criteria:

* Parent/legal guardian has provided informed consent (child has provided assent if needed)
* 5-16 years of age with physician-diagnosed asthma
* Evidence of poor asthma control defined as either:

Hospitalization at Duke Children's Hospital within past 30 days or, ACQ6 \> 1.0 during ambulatory visit to Duke Asthma Center within 2 weeks

Exclusion Criteria:

* Lack of informed consent
* Any major chronic illness that in the opinion of the PI would interfere with participation in the intervention or completion of the study procedures
* Inability to complete baseline measurements in a satisfactory manner according to the judgment of the research coordinator or PI
* Family is planning to move households in the next 2 months
* Parent/Caregiver unable to consent in English
* Sensitivity or allergy to silicone

Primary outcomes:
measure: Number of completed home visits as measured by completion logs
timeFrame: 2 months
measure: Number of completion of the post-intervention phone visit as measured by call logs
timeFrame: Four Months
measure: Number of caregiver reporting satisfaction with intervention as measured by survey responses
timeFrame: Four Month
Secondary outcomes:
measure: Change in Environmental Wristband Markers
timeFrame: 3 weeks and 7 weeks
measure: Change in Indoor Air Quality measured by questionnaire
timeFrame: 3 weeks and 7 weeks
measure: Change in Asthma Symptoms
timeFrame: 1 week and 4 months
measure: Change in Spirometry Values as measured by spirometric measures
timeFrame: 1 week and 4 months
measure: Change in Asthma Symptoms
timeFrame: 1 week and 4 months
measure: Change in Spirometry Values as measured by spirometric measures
timeFrame: 1 week and 4 months
measure: Change in Spirometry Values as measured by spirometric measures
timeFrame: 1 week and 4 months
measure: Change in Spirometry Values as measured by spirometric measures
timeFrame: 1 week and 4 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Jason E Lang, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: