Durham Healthy Breathing in Healthy Homes Project

NCT04119271 | Completed

• 1 other identifier: Pro00102762
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Poor Asthma Control

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Change in Environmental Wristband Markers

  3 weeks and 7 weeks

• Change in Indoor Air Quality measured by questionnaire

  3 weeks and 7 weeks

• Change in Asthma Symptoms

  1 week and 4 months

• Change in Spirometry Values as measured by spirometric measures

  1 week and 4 months

• Change in Asthma Symptoms

  1 week and 4 months

Study Arms (1)

Breathe Easy at Home Kit Products

OTHER

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

Interventions

Breathe Easy at Home Kit Products OTHER

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.

Breathe Easy at Home Kit Products

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Parent/legal guardian has provided informed consent (child has provided assent if needed)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Reinvestment Partners: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Study Officials

• Jason E Lang, MD, MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 8, 2019
• Study Start: May 18, 2022
• Primary Completion: May 11, 2023
• Study Completion: May 11, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)