AsthmaNCT02700542
Asthma and Pest Control Study: Demonstrating Return-on-Investment for In-Home Pest Control for Children With Persistent Asthma
A study testing Integrated Pest Management in people with Asthma, run by New York City Department of Health and Mental Hygiene at 2 sites in United States.
Trial summary
The New York City Department of Health and Mental Hygiene and Montefiore Medical Center, with the Fund for Public Health of New York (FPHNY), DOHMH's fiscal agent, are partnering on a study to evaluate the feasibility, health outcomes and return-on-investment of a single, integrated pest management (IPM) intervention… Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Integrated Pest Management
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 384 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 May 2014to 30 Jun 2017
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Current residence in the Bronx, Harlem and Northern Manhattan with no plans to move within the recruitment period (3 months) outside the Bronx, Harlem or Northern Manhattan
- Families with plans to move within the recruitment period to another location in the Bronx, Harlem, or Northern Manhattan will be placed on list to be called at the end of the recruitment period to reassess eligibility at that time, if the sample size has not yet been achieved.
- Age: 5-12 years
- Persistent asthma or currently prescribed inhaled corticosteroids/other prevention medication
- Persistent asthma (including mild, moderate or severe), according to National Heart Lung and Blood Institute (NHLBI) criteria:
- Experiencing symptoms more than 2 days per week in past month ii. Awaking at night due to symptoms more than 2 times per month iii. Use of SABA meds (i.e., albuterol) for symptom control (not prevention) more than 2 days per week in past month iv. Any interference with daily activity v. Having exacerbations requiring oral systemic corticosteroids 2 or more time per year
Show all 12Show fewer
- Any past-year urgent care visits for asthma:
- ED visits
- Hospitalizations
- Parent-reported pest infestation - cockroaches or mice - in the home
- Have a working phone
- Caregiver primary language of English or Spanish
Who cannot join
- Child living in foster care
- Current residence in shelter or other similar temporary accommodation in the Bronx, Harlem, or Northern Manhattan
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New York City Department of Health and Mental Hygiene
New York, New York, 10013
Montefiore Medical Center
The Bronx, New York, 10467
About this study
The New York City Department of Health and Mental Hygiene and Montefiore Medical Center, with the Fund for Public Health of New York (FPHNY), DOHMH's fiscal agent, are partnering on a study to evaluate the feasibility, health outcomes and return-on-investment of a single, integrated pest management (IPM) intervention for Bronx, Harlem, and Northern Manhattan children aged 5 to 12 with persistent asthma who are living in homes with pests. By demonstrating cost effectiveness, this study could provide the basis for health insurance coverage of an IPM visit embedded in clinical treatment plans for high-risk asthma patients living with pests.
Asthma is the most common childhood disease in New York City, and both prevalence and hospitalization rates are highest in high-poverty neighborhoods. The greatest individual and community-level factor associated with asthma disparities is varying exposure to triggers in the home, most notably cockroaches and mice. Asthma health care costs are significant, and prevention efforts to reduce triggers could result in improved outcomes and significant cost savings. Unlike traditional pest control, which relies on pesticides, IPM eliminates pests and prevents re-infestation by addressing housing conditions conducive to pests and with safe, targeted use of pesticides. This project targets low-income children with the potential to significantly improve their health and well-being. A total of 400 families - 400+ children which includes screened and recruited siblings - will be recruited on to the study.
The study is designed to evaluate an inexpensive and scalable environmental intervention for asthma that can be replicated in other New York City neighborhoods and incorporated into any urban healthcare setting in New York State and nationwide.
Read the detailed description
The New York City Department of Health and Mental Hygiene (DOHMH) and Montefiore Medical Center, with the Fund for Public Health of New York, DOHMH's fiscal agent, have partnered on a study to evaluate the feasibility, health outcomes and return-on-investment of a single integrated pest management (IPM) intervention for Bronx, Harlem and Northern Manhattan children aged 5 to 12 with persistent asthma who are living in homes with pests. Principal Investigator (PI) Daniel Kass, MSPH, Deputy Commissioner of the DOHMH Division of Environmental Health, has extensive experience overseeing evaluation of program and policy initiatives, and co-PI Marina Reznik, MD, MS, Associate Professor of Pediatrics at Montefiore, has conducted research on evaluating the impact of a home-based asthma intervention on asthma-related outcomes in children with persistent asthma recruited from Montefiore clinics.
Asthma is the most common childhood disease in New York City, and both prevalence and hospitalization rates are highest in high-poverty neighborhoods. The greatest individual and community-level factor associated with asthma disparities is varying exposure to triggers in the home, most notably cockroaches and mice. Asthma health care costs are significant, and prevention efforts to reduce triggers could result in improved outcomes and significant cost savings. Unlike traditional pest control, which relies solely on pesticides, IPM eliminates pests and prevents re-infestation by addressing housing conditions conducive to pests and with safe, targeted use of pesticides.
The specific goals of the project are to:
- Demonstrate the feasibility of implementing a basic IPM intervention in the homes of children aged 5-12 years with persistent asthma or current prescription for controller medication and past-year history of asthma-related urgent care visits living in households with pest problems.
- Evaluate changes in asthma outcomes and asthma-related health system utilization associated with the IPM intervention.
- Assess the costs and return-on-investment (ROI) for the IPM intervention.
- Report findings and support policies to adopt insurance reimbursement for basic IPM interventions embedded in health service delivery to prevent asthma exacerbations due to pest triggers in the home.
HealthFirst and Affinity, among the largest insurers of pediatric patients in the Bronx, are collaborating with the research team, providing support in recruitment and use of their data on health outcomes among study participants for the evaluation. The research team is also working with pest control experts to establish a well-priced and replicable protocol for IPM best practice. The protocol will build upon DOHMH's prior work to evaluate IPM in public housing, which demonstrated significant reductions in pest populations and allergens in kitchens and bedrooms, with sustained effects. The study aims to contribute to a best-practice model for one-time IPM service in the home that is not only effective in reducing asthma triggers but also practical and readily adoptable in the pest control industry, replacing the current pesticides-only approach. This groundwork is critical to efforts to scale up to meet demand, should IPM intervention become a reimbursable service in asthma care for high-risk children.
This two-year research project will employ a prospective, randomized controlled study design with the random assignment of 400 participants to two groups: intervention and control. Participants in both groups will be followed for a 12-month period with three assessments: at baseline (when recruited), 6 months, and 12 months after-recruitment. The intervention group will receive the IPM service within 2-4 weeks of completion of the baseline assessment. In addition to the intervention, the family will be provided with basic information about good pest-control practices, such as appropriate food storage, and be given a set of food storage containers. The control group will be provided basic pest control information at baseline and will be offered the equivalent intervention, information, and food storage containers after completion of their 12-month assessment. The primary clinical outcome measures will be: asthma-related urgent care (unscheduled ambulatory) visits, asthma-related emergency department (ED) visits, and asthma-related hospitalizations.
The evaluation of this proposed initiative will assess the intervention implementation and costs, its impact on health outcomes, healthcare cost savings or ROI.
This project targets low-income children with the potential to significantly improve their health and well-being. The study has been designed to evaluate an inexpensive and scalable environmental intervention for asthma that can be replicated in other New York City neighborhoods and incorporated into any urban healthcare setting in New York State and nationwide. By demonstrating cost effectiveness, this study could provide the basis for health insurance coverage of an IPM visit embedded in clinical treatment plans for high-risk asthma patients living with pests.
- Conditions
- Asthma
- Being tested
- Integrated Pest Management
- Keywords
- asthma, pest management
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Pest ManagementOther
One-time, in-home, pest intervention for children with persistent asthma living in homes with parent-reported cockroach and/or mouse infestation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Participants randomly assigned to the intervention group will receive the Integrated Pest Management (IPM) treatment 2-4 weeks of completion of the baseline assessment.The IPM protocol for this research will focus on pest control in the bathrooms and kitchen and will include an assessment of the pest problem, thorough cleaning, patching of small holes, identification and referral of any necessary large repairs, and targeted application of safe pesticides as needed. In cases of severe infestation, a second treatment visit might be required in the home.
In addition to the intervention, the family will be provided with basic information about good pest-control practices, such as appropriate food storage, and be given a set of food storage containers. Receives: Other: Integrated Pest Management |
| Control | Placebo comparator | Participants randomly assigned to the control group will be offered the equivalent intervention, information, and food storage containers after completion of their 12-month assessment. Receives: Other: Integrated Pest Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in counts of urgent care (unscheduled ambulatory) visits at 6 months
Measured: Baseline to 6-months
Change from baseline in costs of urgent care (unscheduled ambulatory) visits at 6 months
Measured: Baseline to 6-Months
Change from 6-months in counts of urgent care (unscheduled ambulatory) visits at 12 months
Measured: 6 months and 12 months
Change from 6-months in costs of urgent care (unscheduled ambulatory) visits at 12 months
Measured: 6 months and 12 months
Change from baseline in counts of urgent care (unscheduled ambulatory) visits at 12 months
Measured: Baseline and 12 months
Change from baseline in costs urgent care (unscheduled ambulatory) visits at 12 months
Measured: Baseline and 12 months
Change from baseline in counts of Emergency Department visits at 6 months
Measured: Baseline to 6 months
Change from baseline in costs of Emergency Department visits at 6 months
Measured: Baseline to 6 months
Change from 6-months in counts of Emergency Department visits at 12 months
Measured: 6 month to 12 month
Change from 6-months in costs of Emergency Department visits at 12 months
Measured: 6 month to 12 month
Change from baseline in counts of Emergency Department visits at 12 months
Measured: Baseline to 12 months
Change from baseline in costs of Emergency Department visits at 12 months
Measured: Baseline to 12 months
Change from baseline in counts of hospitalizations at 6 months
Measured: Baseline to 6 months
Change from baseline in costs of hospitalizations at 6 months
Measured: Baseline to 6 months
Change from 6 months in counts of hospitalizations at 12 months
Measured: 6 months to 12 months
Change from 6 months in costs of hospitalizations at 12 months
Measured: 6 months to 12 months
Change from baseline in counts of hospitalizations at 12 months
Measured: Baseline to 12 months
Change from baseline in costs of hospitalizations at 12 months
Measured: Baseline to 12 months
Secondary outcomes (9)
Change from baseline in number of symptom days per 2-weeks (Participant Reported Outcome) at 6 months
Mean number of caregiver-reported asthma symptom days in the past 2 weeks (as per National Cooperative Inner-City Asthma Study), calculated as the maximum of 3 measures:
- Number of days when the child had wheezing, tightness in the chest, or cough; ii. Number of nights when the child lost sleep because of asthma iii. Number of days the child slowed down or stopped regular play or activities because of asthma.
Measured: Baseline to 6 months
Change from 6 months in number of symptom days per 2-weeks (participant Reported Outcome) at 12 months
Mean number of caregiver-reported asthma symptom days in the past 2 weeks (as per National Cooperative Inner-City Asthma Study), calculated as the maximum of 3 measures:
- Number of days when the child had wheezing, tightness in the chest, or cough; ii. Number of nights when the child lost sleep because of asthma iii. Number of days the child slowed down or stopped regular play or activities because of asthma.
Measured: 6 months to 12 months
Change from baseline in number of symptom days per 2-weeks (participant reported outcome) at 12 months
Mean number of caregiver-reported asthma symptom days in the past 2 weeks (as per National Cooperative Inner-City Asthma Study), calculated as the maximum of 3 measures:
- Number of days when the child had wheezing, tightness in the chest, or cough; ii. Number of nights when the child lost sleep because of asthma iii. Number of days the child slowed down or stopped regular play or activities because of asthma.
Measured: Baseline to 12 months
Change from Baseline in the Number of Days Child Missed School (Participant Reported Outcome) at 6 months
Measured: Baseline to 6 months
Change from 6 Months in the Number of Days Child Missed School (Participant Reported Outcome) at 12 months
Measured: 6 months to 12 months
Change from Baseline in the Number of Days Child Missed School (Participant Reported Outcome) at 12 months
Measured: Baseline to 12 months
Change from Baseline in the Number of Days Parent Missed Work (Participant Reported Outcome) at 6 Months
Measured: Baseline to 6 Months
Change from 6 Months in the Number of Days Parent Missed Work (Participant Reported Outcome) at 12Months
Measured: 6 Months to 12 Months
Change from Baseline in the Number of Days Parent Missed Work (Participant Reported Outcome) at 12Months
Measured: Baseline to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study start21 May 2014
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York City Department of Health and Mental Hygiene
- Sponsor type
- Other government
- Collaborators
- Montefiore Medical Center, Healthfirst, Affinity Health Plan
- Responsible party
- Sponsor
- Investigators
- Daniel Kass, MSPH, Principal investigator, NYC Department of Health and Mental HygieneMarina Reznik, MD, MS, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700542
- Sponsor's protocol ID
- 13-097
- Status last verified
- Jul 2019
- First submitted
- 31 Mar 2015
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma and Pest Control Study: Demonstrating Return-on-Investment for In-Home Pest Control for Children With Persistent Asthma
- ClinicalTrials.gov ID
- NCT02700542
- Acronym / sponsor ID
- 13-097
- Conditions
- Asthma
- Keywords
- asthma, pest management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- New York City Department of Health and Mental HygieneOther government
- Collaborators
- Montefiore Medical Center, Healthfirst, Affinity Health Plan
- Study start
- 21 May 2014 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 7 Mar 2016 (estimated)
- 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 New York City Department of Health and Mental Hygiene and Montefiore Medical Center, with the Fund for Public Health of New York (FPHNY), DOHMH's fiscal agent, are partnering on a study to evaluate the feasibility, health outcomes and return-on-investment of a single, integrated pest management (IPM) intervention for Bronx, Harlem, and Northern Manhattan children aged 5 to 12 with persistent asthma who are living in homes with pests. By demonstrating cost effectiveness, this study could provide the basis for health insurance coverage of an IPM visit embedded in clinical treatment plans for high-risk asthma patients living with pests.
Asthma is the most common childhood disease in New York City, and both prevalence and hospitalization rates are highest in high-poverty neighborhoods. The greatest individual and community-level factor associated with asthma disparities is varying exposure to triggers in the home, most notably cockroaches and mice. Asthma health care costs are significant, and prevention efforts to reduce triggers could result in improved outcomes and significant cost savings. Unlike traditional pest control, which relies on pesticides, IPM eliminates pests and prevents re-infestation by addressing housing conditions conducive to pests and with safe, targeted use of pesticides. This project targets low-income children with the potential to significantly improve their health and well-being. A total of 400 families - 400+ children which includes screened and recruited siblings - will be recruited on to the study.
The study is designed to evaluate an inexpensive and scalable environmental intervention for asthma that can be replicated in other New York City neighborhoods and incorporated into any urban healthcare setting in New York State and nationwide.
Detailed description
The New York City Department of Health and Mental Hygiene (DOHMH) and Montefiore Medical Center, with the Fund for Public Health of New York, DOHMH's fiscal agent, have partnered on a study to evaluate the feasibility, health outcomes and return-on-investment of a single integrated pest management (IPM) intervention for Bronx, Harlem and Northern Manhattan children aged 5 to 12 with persistent asthma who are living in homes with pests. Principal Investigator (PI) Daniel Kass, MSPH, Deputy Commissioner of the DOHMH Division of Environmental Health, has extensive experience overseeing evaluation of program and policy initiatives, and co-PI Marina Reznik, MD, MS, Associate Professor of Pediatrics at Montefiore, has conducted research on evaluating the impact of a home-based asthma intervention on asthma-related outcomes in children with persistent asthma recruited from Montefiore clinics.
Asthma is the most common childhood disease in New York City, and both prevalence and hospitalization rates are highest in high-poverty neighborhoods. The greatest individual and community-level factor associated with asthma disparities is varying exposure to triggers in the home, most notably cockroaches and mice. Asthma health care costs are significant, and prevention efforts to reduce triggers could result in improved outcomes and significant cost savings. Unlike traditional pest control, which relies solely on pesticides, IPM eliminates pests and prevents re-infestation by addressing housing conditions conducive to pests and with safe, targeted use of pesticides.
The specific goals of the project are to:
- Demonstrate the feasibility of implementing a basic IPM intervention in the homes of children aged 5-12 years with persistent asthma or current prescription for controller medication and past-year history of asthma-related urgent care visits living in households with pest problems.
- Evaluate changes in asthma outcomes and asthma-related health system utilization associated with the IPM intervention.
- Assess the costs and return-on-investment (ROI) for the IPM intervention.
- Report findings and support policies to adopt insurance reimbursement for basic IPM interventions embedded in health service delivery to prevent asthma exacerbations due to pest triggers in the home.
HealthFirst and Affinity, among the largest insurers of pediatric patients in the Bronx, are collaborating with the research team, providing support in recruitment and use of their data on health outcomes among study participants for the evaluation. The research team is also working with pest control experts to establish a well-priced and replicable protocol for IPM best practice. The protocol will build upon DOHMH's prior work to evaluate IPM in public housing, which demonstrated significant reductions in pest populations and allergens in kitchens and bedrooms, with sustained effects. The study aims to contribute to a best-practice model for one-time IPM service in the home that is not only effective in reducing asthma triggers but also practical and readily adoptable in the pest control industry, replacing the current pesticides-only approach. This groundwork is critical to efforts to scale up to meet demand, should IPM intervention become a reimbursable service in asthma care for high-risk children.
This two-year research project will employ a prospective, randomized controlled study design with the random assignment of 400 participants to two groups: intervention and control. Participants in both groups will be followed for a 12-month period with three assessments: at baseline (when recruited), 6 months, and 12 months after-recruitment. The intervention group will receive the IPM service within 2-4 weeks of completion of the baseline assessment. In addition to the intervention, the family will be provided with basic information about good pest-control practices, such as appropriate food storage, and be given a set of food storage containers. The control group will be provided basic pest control information at baseline and will be offered the equivalent intervention, information, and food storage containers after completion of their 12-month assessment. The primary clinical outcome measures will be: asthma-related urgent care (unscheduled ambulatory) visits, asthma-related emergency department (ED) visits, and asthma-related hospitalizations.
The evaluation of this proposed initiative will assess the intervention implementation and costs, its impact on health outcomes, healthcare cost savings or ROI.
This project targets low-income children with the potential to significantly improve their health and well-being. The study has been designed to evaluate an inexpensive and scalable environmental intervention for asthma that can be replicated in other New York City neighborhoods and incorporated into any urban healthcare setting in New York State and nationwide. By demonstrating cost effectiveness, this study could provide the basis for health insurance coverage of an IPM visit embedded in clinical treatment plans for high-risk asthma patients living with pests.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: Integrated Pest ManagementParticipants randomly assigned to the intervention group will receive the Integrated Pest Management (IPM) treatment 2-4 weeks of completion of the baseline assessment.The IPM protocol for this research will focus on pest control in the bathrooms and kitchen and will include an assessment of the pest problem, thorough cleaning, patching of small holes, identification and referral of any necessary large repairs, and targeted application of safe pesticides as needed. In cases of severe infestation, a second treatment visit might be required in the home. In addition to the intervention, the family will be provided with basic information about good pest-control practices, such as appropriate food storage, and be given a set of food storage containers. |
| Control | Placebo comparator | Other: Integrated Pest ManagementParticipants randomly assigned to the control group will be offered the equivalent intervention, information, and food storage containers after completion of their 12-month assessment. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Current residence in the Bronx, Harlem and Northern Manhattan with no plans to move within the recruitment period (3 months) outside the Bronx, Harlem or Northern Manhattan
- Age: 5-12 years
- Persistent asthma or currently prescribed inhaled corticosteroids/other prevention medication
- Persistent asthma (including mild, moderate or severe), according to National Heart Lung and Blood Institute (NHLBI) criteria:
- Any past-year urgent care visits for asthma:
Key exclusion criteria (2 listed)
- Child living in foster care
- Current residence in shelter or other similar temporary accommodation in the Bronx, Harlem, or Northern Manhattan
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 |
|---|---|---|
| Integrated Pest ManagementOne-time, in-home, pest intervention for children with persistent asthma living in homes with parent-reported cockroach and/or mouse infestation. | Other | Control, Intervention |
Primary outcome
Change from baseline in counts of urgent care (unscheduled ambulatory) visits at 6 months
Time frame: Baseline to 6-months
Change from baseline in costs of urgent care (unscheduled ambulatory) visits at 6 months
Time frame: Baseline to 6-Months
Change from 6-months in counts of urgent care (unscheduled ambulatory) visits at 12 months
Time frame: 6 months and 12 months
Change from 6-months in costs of urgent care (unscheduled ambulatory) visits at 12 months
Time frame: 6 months and 12 months
Change from baseline in counts of urgent care (unscheduled ambulatory) visits at 12 months
Time frame: Baseline and 12 months
Change from baseline in costs urgent care (unscheduled ambulatory) visits at 12 months
Time frame: Baseline and 12 months
Change from baseline in counts of Emergency Department visits at 6 months
Time frame: Baseline to 6 months
Change from baseline in costs of Emergency Department visits at 6 months
Time frame: Baseline to 6 months
Change from 6-months in counts of Emergency Department visits at 12 months
Time frame: 6 month to 12 month
Change from 6-months in costs of Emergency Department visits at 12 months
Time frame: 6 month to 12 month
Change from baseline in counts of Emergency Department visits at 12 months
Time frame: Baseline to 12 months
Change from baseline in costs of Emergency Department visits at 12 months
Time frame: Baseline to 12 months
Change from baseline in counts of hospitalizations at 6 months
Time frame: Baseline to 6 months
Change from baseline in costs of hospitalizations at 6 months
Time frame: Baseline to 6 months
Change from 6 months in counts of hospitalizations at 12 months
Time frame: 6 months to 12 months
Change from 6 months in costs of hospitalizations at 12 months
Time frame: 6 months to 12 months
Change from baseline in counts of hospitalizations at 12 months
Time frame: Baseline to 12 months
Change from baseline in costs of hospitalizations at 12 months
Time frame: Baseline to 12 months
9 secondary outcomes
Change from baseline in number of symptom days per 2-weeks (Participant Reported Outcome) at 6 months
Time frame: Baseline to 6 months
Change from 6 months in number of symptom days per 2-weeks (participant Reported Outcome) at 12 months
Time frame: 6 months to 12 months
Change from baseline in number of symptom days per 2-weeks (participant reported outcome) at 12 months
Time frame: Baseline to 12 months
Change from Baseline in the Number of Days Child Missed School (Participant Reported Outcome) at 6 months
Time frame: Baseline to 6 months
Change from 6 Months in the Number of Days Child Missed School (Participant Reported Outcome) at 12 months
Time frame: 6 months to 12 months
Change from Baseline in the Number of Days Child Missed School (Participant Reported Outcome) at 12 months
Time frame: Baseline to 12 months
Change from Baseline in the Number of Days Parent Missed Work (Participant Reported Outcome) at 6 Months
Time frame: Baseline to 6 Months
Change from 6 Months in the Number of Days Parent Missed Work (Participant Reported Outcome) at 12Months
Time frame: 6 Months to 12 Months
Change from Baseline in the Number of Days Parent Missed Work (Participant Reported Outcome) at 12Months
Time frame: Baseline to 12 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 17 Jul 2019.
- 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.
Daniel Kass, MSPH principal investigator
NYC Department of Health and Mental Hygiene
Marina Reznik, MD, MS principal investigator
Montefiore Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Pest Management in people with Asthma, run by New York City Department of Health and Mental Hygiene at 2 sites 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 12 inclusion and 2 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 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Change from baseline in counts of urgent care (unscheduled ambulatory) visits at 6 months (time frame: Baseline to 6-months). The study lists 18 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 17 Jul 2019.