Poor Asthma ControlDHBHHNCT04119271
Durham Healthy Breathing in Healthy Homes Project
A study testing Breathe Easy at Home Kit Products in people with Poor Asthma Control, run by Duke University at 1 site in United States.
Trial summary
To determine if Home-based Environmental Interventions (HEI) that improve home air-quality problems can improve asthma outcomes. Participants will benefit through home-based environmental interventions that improve home air-quality problems and improve asthma outcomes. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Poor Asthma Control
- What is being tested?
- Breathe Easy at Home Kit Products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2022to 11 May 2023
- 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 5 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)
- 5-16 years of age with physician-diagnosed asthma
- Evidence of poor asthma control defined as either:
- Hospitalization at Duke Children's Hospital within past 30 days or, ACQ6 > 1.0 during ambulatory visit to Duke Asthma Center within 2 weeks
Who cannot join
- Lack of informed consent
- Any major chronic illness that in the opinion of the 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
- Family is planning to move households in the next 2 months
- Parent/Caregiver unable to consent in English
- Sensitivity or allergy to silicone
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Durham Healthy Breathing in Healthy Homes Project: A Duke-Reinvestment Partners Collaborative
To determine if Home-based Environmental Interventions (HEI) that improve home air-quality problems can improve asthma outcomes. Participants will benefit through home-based environmental interventions that improve home air-quality problems and improve asthma outcomes. All participants will receive a Breath Easy at Home Kit, which could help with reducing environmental exposures. The primary objective is to assess the feasibility and acceptability of the HEI measured by the proportion of families completing intervention components and proportion of caregivers expressing satisfaction with intervention components. Secondary objective is to explore the efficacy of a HEI on reducing environmental exposures measured using personal wristband monitors.
Exploratory objective is improvements in asthma control following HEI measured using asthma control scores and lung function. The fourth objection is to explore correlations between demographics, body weight, housing characteristics (smokers, electronic cigarette use, number of pets, housing type) with measures of acceptability, satisfaction and improved exposure markers.
Read the detailed description
The investigator propses a 23-week prospective, open label, single center, environmental remediation intervention study in 5-16 year old children with poor asthma control. At visit 1, wristbands will be dispensed and collected to estimate exposure to a suite of common organic contaminants including phthalates, organophosphate esters, several pesticides and polyaromatic hydrocarbons (PAH). During the initial home visit, the Healthy Homes Housing Specialist will conduct an environmental home assessment to identify asthma triggers in accordance with the EPA's recommendations for helping children with asthma. The Housing Specialist will follow the EPA document Home Characteristics and Asthma Triggers, and will provide the family with a Breathe Easy at Home Kit. The Specialist will provide training and instructions on how to use each of the supplies provided in the kit. If the Housing Specialist identifies necessary home repairs during the assessment process, the Housing Specialist can refer the family to organizations that offer home repairs, modifications, and weatherization services. The specialist will discuss the importance of clean air for maintaining lung health for all family members and will discuss the importance of banning of any indoor smoking, smoking anywhere around the household and smoking in any household automobiles (even when the child is not present). Follow up phone calls will be conducted to answer questions, complete questionnaires and complete a household environmental interview.
- Conditions
- Poor Asthma Control
- Being tested
- Breathe Easy at Home Kit Products
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathe Easy at Home Kit ProductsOther
HEPA filtered upright vacuum cleaner, HEPA-filtered Air Purifier, Hypoallergenic latex free mattress cover, box spring cover, and two pillow covers, Healthier alternative to most household cleaners, Non- toxic glue type pest control devices for rodent control and a combination of safe products to locate and kill roaches.
| Study group | Role | What they receive |
|---|---|---|
| Breathe Easy at Home Kit Products | Other | Families will be provided with a Breathe Easy at Home Kit. These kits will include:
a HEPA filtered upright vacuum cleaner, a HEPA-filtered Air Purifier, a Hypoallergenic latex free mattress cover, box spring cover, and two pillow covers, Healthier alternative to most household cleaners, Non- toxic glue type pest control devices for rodent control, and a combination of safe products to locate and kill roaches. Receives: Other: Breathe Easy at Home Kit Products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of completed home visits as measured by completion logs
Measured: 2 months
Number of completion of the post-intervention phone visit as measured by call logs
Measured: Four Months
Number of caregiver reporting satisfaction with intervention as measured by survey responses
Measured: Four Month
Secondary outcomes (8)
Change in Environmental Wristband Markers
changes in targeted environmental wristband markers of exposure to organic contaminants in the home environment, including phthalates, organophosphate esters, several pesticides, and polyaromatic hydrocarbon (PAH) markers evaluated using personal silicone wristband monitors. Paired t-tests (or Wilcoxon signed rank tests for non-parametric data) will be used to assess post-intervention changes in targeted wristbands toxin levels.The relationship between changes in these outcomes and measures of intervention adherence will be analyzed using Pearson correlations and ANOVA trend testing as appropriate.
Measured: 3 weeks and 7 weeks
Change in Indoor Air Quality measured by questionnaire
Sponsor developed questionnaire-15 to 20 questions asking about air quality.
Measured: 3 weeks and 7 weeks
Change in Asthma Symptoms
Change in asthma symptom control measured by the asthma control questionnaire 6 (ACQ6) (ambulatory participants only).
Measured: 1 week and 4 months
Change in Spirometry Values as measured by spirometric measures
Impulse Oscillometry (IOS) simply requires the child to breathe in and out through a mouthpiece for 20-30 seconds. During breathing, a loudspeaker delivers a quiet pulse-shaped pressure-flow signal to the respiratory system. Spirometric measures is the forced vital capacity (FVC),
Measured: 1 week and 4 months
Change in Asthma Symptoms
Improvements in asthma control following HEI measured using asthma control scores and lung function. For patients enrolled in the ambulatory setting, change in FEV1, FEV1/FVC by spirometry will be calculated.
Measured: 1 week and 4 months
Change in Spirometry Values as measured by spirometric measures
The Spirometer measure is theforced expiratory volume in 1 second (FEV1),
Measured: 1 week and 4 months
Change in Spirometry Values as measured by spirometric measures
The Spirometeric Measure is the FEV1/FVC ratio
Measured: 1 week and 4 months
Change in Spirometry Values as measured by spirometric measures
The Spirometric Measure is the forced expiratory flow average over 25-75% of FVC (FEF25-75).
Measured: 1 week and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start18 May 2022
- Primary completion11 May 2023
- Study completion11 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Asthma ControlStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Reinvestment Partners
- Responsible party
- Sponsor
- Investigators
- Jason E Lang, MD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119271
- Sponsor's protocol ID
- Pro00102762
- Acronym
- DHBHH
- Status last verified
- Feb 2023
- First submitted
- 3 Oct 2019
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Durham Healthy Breathing in Healthy Homes Project: A Duke-Reinvestment Partners Collaborative
- ClinicalTrials.gov ID
- NCT04119271
- Acronym / sponsor ID
- DHBHH / Pro00102762
- Conditions
- Poor Asthma Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Reinvestment Partners
- Study start
- 18 May 2022 (actual)
- Primary completion
- 11 May 2023 (actual)
- Study completion
- 11 May 2023 (actual)
- First posted
- 8 Oct 2019 (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.
To determine if Home-based Environmental Interventions (HEI) that improve home air-quality problems can improve asthma outcomes. Participants will benefit through home-based environmental interventions that improve home air-quality problems and improve asthma outcomes. All participants will receive a Breath Easy at Home Kit, which could help with reducing environmental exposures. The primary objective is to assess the feasibility and acceptability of the HEI measured by the proportion of families completing intervention components and proportion of caregivers expressing satisfaction with intervention components. Secondary objective is to explore the efficacy of a HEI on reducing environmental exposures measured using personal wristband monitors.
Exploratory objective is improvements in asthma control following HEI measured using asthma control scores and lung function. The fourth objection is to explore correlations between demographics, body weight, housing characteristics (smokers, electronic cigarette use, number of pets, housing type) with measures of acceptability, satisfaction and improved exposure markers.
Detailed description
The investigator propses a 23-week prospective, open label, single center, environmental remediation intervention study in 5-16 year old children with poor asthma control. At visit 1, wristbands will be dispensed and collected to estimate exposure to a suite of common organic contaminants including phthalates, organophosphate esters, several pesticides and polyaromatic hydrocarbons (PAH). During the initial home visit, the Healthy Homes Housing Specialist will conduct an environmental home assessment to identify asthma triggers in accordance with the EPA's recommendations for helping children with asthma. The Housing Specialist will follow the EPA document Home Characteristics and Asthma Triggers, and will provide the family with a Breathe Easy at Home Kit. The Specialist will provide training and instructions on how to use each of the supplies provided in the kit. If the Housing Specialist identifies necessary home repairs during the assessment process, the Housing Specialist can refer the family to organizations that offer home repairs, modifications, and weatherization services. The specialist will discuss the importance of clean air for maintaining lung health for all family members and will discuss the importance of banning of any indoor smoking, smoking anywhere around the household and smoking in any household automobiles (even when the child is not present). Follow up phone calls will be conducted to answer questions, complete questionnaires and complete a household environmental interview.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breathe Easy at Home Kit Products | Other | Other: Breathe Easy at Home Kit ProductsFamilies will be provided with a Breathe Easy at Home Kit. These kits will include: a HEPA filtered upright vacuum cleaner, a HEPA-filtered Air Purifier, a Hypoallergenic latex free mattress cover, box spring cover, and two pillow covers, Healthier alternative to most household cleaners, Non- toxic glue type pest control devices for rodent control, and a combination of safe products to locate and kill roaches. |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Parent/legal guardian has provided informed consent (child has provided assent if needed)
- 5-16 years of age with physician-diagnosed asthma
- Evidence of poor asthma control defined as either:
- Hospitalization at Duke Children's Hospital within past 30 days or, ACQ6 > 1.0 during ambulatory visit to Duke Asthma Center within 2 weeks
Key exclusion criteria (6 listed)
- Lack of informed consent
- Any major chronic illness that in the opinion of the 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
- Family is planning to move households in the next 2 months
- Parent/Caregiver unable to consent in English
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 |
|---|---|---|
| Breathe Easy at Home Kit ProductsHEPA filtered upright vacuum cleaner, HEPA-filtered Air Purifier, Hypoallergenic latex free mattress cover, box spring cover, and two pillow covers, Healthier alternative to most household cleaners, Non- toxic glue type pest control devices for rodent control and a combination of safe products to locate and kill roaches. | Other | Breathe Easy at Home Kit Products |
Primary outcome
Number of completed home visits as measured by completion logs
Time frame: 2 months
Number of completion of the post-intervention phone visit as measured by call logs
Time frame: Four Months
Number of caregiver reporting satisfaction with intervention as measured by survey responses
Time frame: Four Month
8 secondary outcomes
Change in Environmental Wristband Markers
Time frame: 3 weeks and 7 weeks
Change in Indoor Air Quality measured by questionnaire
Time frame: 3 weeks and 7 weeks
Change in Asthma Symptoms
Time frame: 1 week and 4 months
Change in Spirometry Values as measured by spirometric measures
Time frame: 1 week and 4 months
Change in Asthma Symptoms
Time frame: 1 week and 4 months
Change in Spirometry Values as measured by spirometric measures
Time frame: 1 week and 4 months
Change in Spirometry Values as measured by spirometric measures
Time frame: 1 week and 4 months
Change in Spirometry Values as measured by spirometric measures
Time frame: 1 week and 4 months
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 4 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Poor Asthma Control
Recruiting
Asthma Intervention With Residential Ventilation and Air Cleaner (AIRVAC) Study
Asthma Control, Pulmonary Function
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 E Lang, MD, MPH 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 Breathe Easy at Home Kit Products in people with Poor Asthma Control, 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 4 inclusion and 6 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 4 Dec 2023. 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?
Number of completed home visits as measured by completion logs (time frame: 2 months). The study lists 3 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 4 Dec 2023.