Asthma in Children Clinical Trial
— DRCOfficial title:
The Duke-Reinvestment Partners Community Collaborative (DRC)- Healthy Homes
NCT number | NCT05934370 |
Other study ID # | Pro00113089 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 20, 2023 |
Est. completion date | August 2024 |
Verified date | July 2023 |
Source | Duke University |
Contact | Erin Frost, BS |
Phone | 919-613-3320 |
erin.frost[@]duke.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Health System | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
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 |
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