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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Asthma in Children

Intervention / Treatment
-----------------
* Other: Home-Based Environmental Interventions (HEI)


Participation Criteria
=================
Eligibility Criteria
-----------------
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: 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 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

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study Participants<br>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)<br>* 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.<br>|

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 |