Clinical trial NCT05934370: The Duke-Reinvestment Partners Community Collaborative (DRC)- Healthy Homes
Official title: The Duke-Reinvestment Partners Community Collaborative (DRC)- Healthy Homes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma in Children
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 36
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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:

  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

Primary outcomes:
measure: Patient Satisfaction
timeFrame: Week 10
measure: Caregiver Satisfacation Survey
timeFrame: Week 10
measure: Change in Air -Quality Index
timeFrame: Week 4, Week 10
measure: Asthma healthcare utilization measured by number of clinic visits needed
timeFrame: Through study completion, an average of 24 weeks
measure: Asthma healthcare utilization measured by number of Emergency Department visits
timeFrame: Through study completion, an average of 24 weeks
measure: Asthma healthcare utilization measured by number of urgent care visits
timeFrame: Through study completion, an average of 24 weeks
measure: Asthma healthcare utilization measured by number of hospitalizations
timeFrame: Through study completion, an average of 24 weeks
Secondary outcomes:
measure: Study Completion
timeFrame: Through study completion, an average of 24 weeks
measure: Change in Air Quality of Formaldehyde measured by a Temtop M10
timeFrame: Week 8
measure: Change in Air Quality of Particulate Matter (PM) measured by a Temtop M10
timeFrame: Week 8
measure: Change in Air Quality of TVOC measured by a Temtop M10
timeFrame: Week 8
measure: Change in Air Quality measured by a Temtop M10
timeFrame: Week 8
measure: Air Quality changes of Particulate Matter (PM) 2.5 measured by a Temtop M2000c
timeFrame: Week 8
measure: Air Quality changes of particles measured by a Temtop M2000c
timeFrame: Week 8
measure: Air Quality changes of carbon dioxide measured by a Temtop M2000c
timeFrame: Week 8
measure: Air Quality changes of particulate matter (PM 10) measured by a Temtop M2000c
timeFrame: Week 8
measure: Air Quality changes measured by patient's air purifier
timeFrame: Week 8
measure: Measurement of lung function
timeFrame: Week 10
measure: Asthma Symptoms measured by the Asthma Control Questionnaire (ACQ 6)
timeFrame: Week 10
measure: Asthma symptoms measured by the Asthma Control Test (ACT or cACT)
timeFrame: Week 10
measure: Asthma symptoms measured by the Duke Asthma Score (DAS)
timeFrame: Week 10
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke University
name: Jason Lang, MD
role: PRINCIPAL_INVESTIGATOR
References: