The Duke-Reinvestment Partners Community Collaborative (DRC)- Healthy Homes (DRC)

The goal of this open-label, single arm home intervention feasibility study is to improve quality of life for children ages 4-16 years with asthma.

The main questions it aims to answer are:

• How can Home-Based Environmental Interventions (HEI) improve home air-quality problems in the home?
• How can HEI improve asthma outcomes in children?

Participants will be receiving HEI and completing asthma surveys.

Study Overview

• Status: Completed
• Conditions: Asthma in Children
• Intervention / Treatment: Other: Home-Based Environmental Interventions (HEI)

Detailed Description

All participants will receive an Intervention Kit, which could help with reducing environmental exposures. Participants will be monitored closely with up to 2 clinic visits, 2 home visits and up to 4 phone call visits. During the home visits, a study team will ask questions about your home and asthma, conduct home assessments, and provide training on use of the home kit.

Participants may benefit from participation in this study through Home-Based Environmental Interventions by improving home air-quality and asthma outcomes. Study duration is approximately 24-30 weeks with 8 weeks of intervention, which includes baseline interview, questionnaires, spirometry testing, and participants receiving an Intervention Kit.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Parent/legal guardian has provided informed consent (child has provided assent if needed)
• 4-16 years of age with medical provider -diagnosed asthma

• Evidence of recent poor asthma control, defined as either:

  1. Asthma exacerbation requiring systemic steroids within 3 month of consent OR
  2. ACQ6 > 1.0; or ACT/cACT ≤ 19 during ambulatory visit within 3 months of consent
• Family lives in one of the following Central NC counties: Alamance, Chatham, Durham, Franklin, Granville, Johnston, Lee, Orange, Person, Vance, or Wake counties
• Family is not planning to move out of one of the approved counties accessible to Reinvestment Partners in the next 6 months

Exclusion Criteria:

• Lack of informed consent
• Any major chronic illness that in the opinion of the Principal Investigator (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
• Parent/Caregiver unable to consent in English or Spanish
• Sensitivity or allergy to silicone

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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: Study Participants; Participants will receive an intervention kit that will include two at-home visits and the following products: child bedroom HEPA-air purifier, HEPA upright vacuum, hypoallergenic dust-mite cover for child's mattress and pillow covers; Non-toxic household cleaning products and non-toxic pest/rodent traps.

Other: Home-Based Environmental Interventions (HEI); Housing Specialist will conduct an environmental home assessment to identify asthma triggers. • The participant will receive the following Breath Easy at Home Kit Products: HEPA filtered upright vacuum cleaner; HEPA-filtered air purifier; Hypoallergenic latex free mattress and pillow covers; Healthier household cleaners; Non-toxic pest control devices for rodent control; Safe products to locate and kill roaches.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	A measure of satisfaction by distributing a satisfaction survey to each patient and caregiver	Week 10
Caregiver Satisfacation Survey	A measure of satisfaction by distributing a satisfaction survey to each patient and caregiver	Week 10
Change in Air -Quality Index	Air-quality index assessments will include: PM2.5, PM10, total VOC's, formaldehyde, carbon dioxide, Air Quality Index) in child's room and main living room using the Temtop M10, Temptop 2000C, and HEPA purifier air quality monitor.	Week 4, Week 10
Asthma healthcare utilization measured by number of clinic visits needed	Determine ongoing need for healthcare utilization for participant's asthma	Through study completion, an average of 24 weeks
Asthma healthcare utilization measured by number of Emergency Department visits	Determine ongoing need for healthcare utilization for participant's asthma	Through study completion, an average of 24 weeks
Asthma healthcare utilization measured by number of urgent care visits	Determine ongoing need for healthcare utilization for participant's asthma	Through study completion, an average of 24 weeks
Asthma healthcare utilization measured by number of hospitalizations	Determine ongoing need for healthcare utilization for participant's asthma	Through study completion, an average of 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study Completion	Study completion will be measured when 30 participants enroll and complete the intervention	Through study completion, an average of 24 weeks
Change in Air Quality of Formaldehyde measured by a Temtop M10	The Temtop M10 will measure the amount of Formaldehyde in the home	Week 8
Change in Air Quality of Particulate Matter (PM) measured by a Temtop M10	The Temtop M10 will measure the amount of Particulate Matter (PM) 2.5 in the home	Week 8
Change in Air Quality of TVOC measured by a Temtop M10	The Temtop M10 will measure the amount of TVOC in the home	Week 8
Change in Air Quality measured by a Temtop M10	The Temtop M10 will measure the air quality in the home	Week 8
Air Quality changes of Particulate Matter (PM) 2.5 measured by a Temtop M2000c	The Temtop M2000c will measure the Particulate Matter (PM)2.5	Week 8
Air Quality changes of particles measured by a Temtop M2000c	The Temtop M2000c will measure the number of particles in the home	Week 8
Air Quality changes of carbon dioxide measured by a Temtop M2000c	The Temtop M2000c will measure the amount of carbon dioxide in the home	Week 8
Air Quality changes of particulate matter (PM 10) measured by a Temtop M2000c	The Temtop M2000c will measure the amount of particulate matter (PM 10) in the home	Week 8
Air Quality changes measured by patient's air purifier	The patient's air purifier will measure the air quality index in the home	Week 8
Measurement of lung function	Lung function will be measure by spirometry	Week 10
Asthma Symptoms measured by the Asthma Control Questionnaire (ACQ 6)	The Asthma Control Questionnaire (ACQ 6) is a 6 question self-report measure of asthma symptoms over the prior week. Items are rated on a sale ranging from 0 (never interferes with daily life) to 6 (interferes very severely with daily life). Higher scores indicate a worse outcome than lower scores.	Week 10
Asthma symptoms measured by the Asthma Control Test (ACT or cACT)	The Asthma Control Test (ACT or cACT) is a 5 question self-report measure of asthma symptoms over the prior four weeks. Items are rated on a scale ranging from 1 (All of the time) to 5 (none of the time). Lower scores indicate a worse outcome than higher scores.	Week 10
Asthma symptoms measured by the Duke Asthma Score (DAS)	The Duke Asthma Score (DAS) is a 6 question self-report measure of asthma symptoms over the prior month. Items are rated on a scale ranging from 0 (never) to 4 (every day). Higher scores indicate a worse outcome than lower scores.	Week 10

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Jason Lang, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2023
• Primary Completion (Actual): November 19, 2024
• Study Completion (Actual): November 19, 2024

Study Registration Dates

• First Submitted: June 26, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Pro00113089

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