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

Asthma in Children Clinical Trial

— DRC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05934370
• Other study ID #: Pro00113089
• Status: Recruiting
• Phase: N/A
• Start date: July 20, 2023
• Est. completion date: August 2024

Study information

• Verified date: July 2023
• Source: Duke University
• Contact: Erin Frost, BS
• Phone: 919-613-3320
• Email: erin.frost[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma in Children

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Satisfaction	A measure of satisfaction by distributing a satisfaction survey to each patient and caregiver	Week 10
Primary	Caregiver Satisfacation Survey	A measure of satisfaction by distributing a satisfaction survey to each patient and caregiver	Week 10
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Study Completion	Study completion will be measured when 30 participants enroll and complete the intervention	Through study completion, an average of 24 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Air Quality measured by a Temtop M10	The Temtop M10 will measure the air quality in the home	Week 8
Secondary	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
Secondary	Air Quality changes of particles measured by a Temtop M2000c	The Temtop M2000c will measure the number of particles in the home	Week 8
Secondary	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
Secondary	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
Secondary	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
Secondary	Measurement of lung function	Lung function will be measure by spirometry	Week 10
Secondary	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
Secondary	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
Secondary	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