Durham Healthy Breathing in Healthy Homes Project (DHBHH)

Durham Healthy Breathing in Healthy Homes Project: A Duke-Reinvestment Partners Collaborative

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.

Study Overview

• Status: Completed
• Conditions: Poor Asthma Control
• Intervention / Treatment: Other: Breathe Easy at Home Kit Products

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nedenia C Parker, BS; Phone Number: 919-684-6127; Email: nedenia.parker@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 16 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Breathe Easy at Home Kit Products; Families will be provided with a Breathe Easy at Home Kit. These kits will include: a HEPA filtered upright vacuum cleaner, a HEPA-filtered Air Purifier, a Hypoallergenic latex free mattress cover, box spring cover, and two pillow covers, Healthier alternative to most household cleaners, Non- toxic glue type pest control devices for rodent control, and a combination of safe products to locate and kill roaches.

Other: Breathe Easy at Home Kit Products; HEPA filtered upright vacuum cleaner, HEPA-filtered Air Purifier, Hypoallergenic latex free mattress cover, box spring cover, and two pillow covers, Healthier alternative to most household cleaners, Non- toxic glue type pest control devices for rodent control and a combination of safe products to locate and kill roaches.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of completed home visits as measured by completion logs	2 months
Number of completion of the post-intervention phone visit as measured by call logs	Four Months
Number of caregiver reporting satisfaction with intervention as measured by survey responses	Four Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Environmental Wristband Markers	changes in targeted environmental wristband markers of exposure to organic contaminants in the home environment, including phthalates, organophosphate esters, several pesticides, and polyaromatic hydrocarbon (PAH) markers evaluated using personal silicone wristband monitors. Paired t-tests (or Wilcoxon signed rank tests for non-parametric data) will be used to assess post-intervention changes in targeted wristbands toxin levels.The relationship between changes in these outcomes and measures of intervention adherence will be analyzed using Pearson correlations and ANOVA trend testing as appropriate.	3 weeks and 7 weeks
Change in Indoor Air Quality measured by questionnaire	Sponsor developed questionnaire-15 to 20 questions asking about air quality.	3 weeks and 7 weeks
Change in Asthma Symptoms	Change in asthma symptom control measured by the asthma control questionnaire 6 (ACQ6) (ambulatory participants only).	1 week and 4 months
Change in Spirometry Values as measured by spirometric measures	Impulse Oscillometry (IOS) simply requires the child to breathe in and out through a mouthpiece for 20-30 seconds. During breathing, a loudspeaker delivers a quiet pulse-shaped pressure-flow signal to the respiratory system. Spirometric measures is the forced vital capacity (FVC),	1 week and 4 months
Change in Asthma Symptoms	Improvements in asthma control following HEI measured using asthma control scores and lung function. For patients enrolled in the ambulatory setting, change in FEV1, FEV1/FVC by spirometry will be calculated.	1 week and 4 months
Change in Spirometry Values as measured by spirometric measures	The Spirometer measure is theforced expiratory volume in 1 second (FEV1),	1 week and 4 months
Change in Spirometry Values as measured by spirometric measures	The Spirometeric Measure is the FEV1/FVC ratio	1 week and 4 months
Change in Spirometry Values as measured by spirometric measures	The Spirometric Measure is the forced expiratory flow average over 25-75% of FVC (FEF25-75).	1 week and 4 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Reinvestment Partners
• Investigators: Principal Investigator: Jason E Lang, MD, MPH, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2022
• Primary Completion (Actual): May 11, 2023
• Study Completion (Actual): May 11, 2023

Study Registration Dates

• First Submitted: October 3, 2019
• First Submitted That Met QC Criteria: October 7, 2019
• First Posted (Actual): October 8, 2019

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: Pro00102762

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No