Asthma in ChildrenDRCNCT05934370
The Duke-Reinvestment Partners Community Collaborative (DRC)- Healthy Homes
A study testing Home-Based Environmental Interventions (HEI) in people with Asthma in Children, run by Duke University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Home-Based Environmental Interventions (HEI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2023to 19 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27710
About this study
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.
Read the 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.
- Conditions
- Asthma in Children
- Being tested
- Home-Based Environmental Interventions (HEI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Home-Based Environmental Interventions (HEI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
A measure of satisfaction by distributing a satisfaction survey to each patient and caregiver
Measured: Week 10
Caregiver Satisfacation Survey
A measure of satisfaction by distributing a satisfaction survey to each patient and caregiver
Measured: 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.
Measured: Week 4, Week 10
Asthma healthcare utilization measured by number of clinic visits needed
Determine ongoing need for healthcare utilization for participant's asthma
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion, an average of 24 weeks
Secondary outcomes (14)
Study Completion
Study completion will be measured when 30 participants enroll and complete the intervention
Measured: 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
Measured: 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
Measured: 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
Measured: Week 8
Change in Air Quality measured by a Temtop M10
The Temtop M10 will measure the air quality in the home
Measured: 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
Measured: Week 8
Air Quality changes of particles measured by a Temtop M2000c
The Temtop M2000c will measure the number of particles in the home
Measured: 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
Measured: 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
Measured: 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
Measured: Week 8
Measurement of lung function
Lung function will be measure by spirometry
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start20 Jul 2023
- Primary completion19 Nov 2024
- Study completion19 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Lang, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934370
- Sponsor's protocol ID
- Pro00113089
- Acronym
- DRC
- Status last verified
- Jul 2024
- First submitted
- 26 Jun 2023
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Duke-Reinvestment Partners Community Collaborative (DRC)- Healthy Homes
- ClinicalTrials.gov ID
- NCT05934370
- Acronym / sponsor ID
- DRC / Pro00113089
- Conditions
- Asthma in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 19 Nov 2024 (actual)
- Study completion
- 19 Nov 2024 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Participants | Other | Other: Home-Based Environmental Interventions (HEI)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. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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:
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Study Participants |
Primary outcome
Patient Satisfaction
Time frame: Week 10
A measure of satisfaction by distributing a satisfaction survey to each patient and caregiver
Caregiver Satisfacation Survey
Time frame: Week 10
A measure of satisfaction by distributing a satisfaction survey to each patient and caregiver
Change in Air -Quality Index
Time frame: Week 4, Week 10
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.
Asthma healthcare utilization measured by number of clinic visits needed
Time frame: Through study completion, an average of 24 weeks
Determine ongoing need for healthcare utilization for participant's asthma
Asthma healthcare utilization measured by number of Emergency Department visits
Time frame: Through study completion, an average of 24 weeks
Determine ongoing need for healthcare utilization for participant's asthma
Asthma healthcare utilization measured by number of urgent care visits
Time frame: Through study completion, an average of 24 weeks
Determine ongoing need for healthcare utilization for participant's asthma
Asthma healthcare utilization measured by number of hospitalizations
Time frame: Through study completion, an average of 24 weeks
Determine ongoing need for healthcare utilization for participant's asthma
14 secondary outcomes
Study Completion
Time frame: Through study completion, an average of 24 weeks
Change in Air Quality of Formaldehyde measured by a Temtop M10
Time frame: Week 8
Change in Air Quality of Particulate Matter (PM) measured by a Temtop M10
Time frame: Week 8
Change in Air Quality of TVOC measured by a Temtop M10
Time frame: Week 8
Change in Air Quality measured by a Temtop M10
Time frame: Week 8
Air Quality changes of Particulate Matter (PM) 2.5 measured by a Temtop M2000c
Time frame: Week 8
Air Quality changes of particles measured by a Temtop M2000c
Time frame: Week 8
Air Quality changes of carbon dioxide measured by a Temtop M2000c
Time frame: Week 8
Air Quality changes of particulate matter (PM 10) measured by a Temtop M2000c
Time frame: Week 8
Air Quality changes measured by patient's air purifier
Time frame: Week 8
Measurement of lung function
Time frame: Week 10
Asthma Symptoms measured by the Asthma Control Questionnaire (ACQ 6)
Time frame: Week 10
Asthma symptoms measured by the Asthma Control Test (ACT or cACT)
Time frame: Week 10
Asthma symptoms measured by the Duke Asthma Score (DAS)
Time frame: Week 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Lang, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-Based Environmental Interventions (HEI) in people with Asthma in Children, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction (time frame: Week 10). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.