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

NCT05934370 | Completed DMC

• 1 other identifier: Pro00113089
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (14)

• Study Completion

  Through study completion, an average of 24 weeks

• Change in Air Quality of Formaldehyde measured by a Temtop M10

  Week 8

• Change in Air Quality of Particulate Matter (PM) measured by a Temtop M10

  Week 8

• Change in Air Quality of TVOC measured by a Temtop M10

  Week 8

• Change in Air Quality measured by a Temtop M10

  Week 8

Study Arms (1)

Study Participants

OTHER

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)

Interventions

Home-Based Environmental Interventions (HEI) OTHER

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.

Study Participants

Eligibility Criteria

• Age: 4 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 medical provider -diagnosed asthma
• Evidence of recent poor asthma control, defined as either:
• Asthma exacerbation requiring systemic steroids within 3 month of consent OR
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

Study Officials

• Jason Lang, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 7, 2023
• Study Start: July 20, 2023
• Primary Completion: November 19, 2024
• Study Completion: November 19, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)