- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02381626
DRIIVE (Data and Research on Interventions to Improve the Vehicular Environment)
The purpose of this study is to look at air quality in cabs and see if the air quality inside taxi cabs is connected to increased risks for lung and heart health problems. Another purpose of the study is to see if putting an air filter inside the car may help improve the air quality and lower health risks.
This is important because air pollution can be harmful to health. Air pollution is made up of very tiny particles (things) floating in the air around us, called particulate matter. Particulate matter is made up of dust, smoke, dirt, and gas fumes and can get into our bodies as we breathe. It has been linked to risk for lung cancer and heart disease. It is important because taxi drivers spend many hours of their day inside their cars.
The investigators hope that this study will help them find out if using air filters inside cabs will help lower the levels of pollution in cabs and reduce its effects on the health of taxi drivers. They will use these results to educate the taxi driver community.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Drivers:
- Full-time New York City cab drivers;
- Non Smokers (assessed by modified BRFSS smoking question within screening tool) ;
- Male;
- Between the ages of 21 and 90;
- No immediate plans (within the next 3 months) to leave the City for vacation or for trips back to their home country
- Driver for at least 3 years*;
- Driving schedule does not include overnight shifts, nor does driver have an additional job overnight;
- Own a smart phone (in order to collect heart rate variability data)
- Should self-report at least "Very well" level of English fluency (according to the standard US census question)
- Have working cigarette lighter receptacle/socket inside taxi cab *The requirement to have worked at least 3 years in the U.S. should minimize any acute health effects/disease due to high levels of contaminants associated with country of origin
Exclusion Criteria:
Drivers:
- Smoker or uses smokeless tobacco products;
- Resides in a smoking household (where 1 or more household members smoke);
- Has a sleep disorder (including insomnia, delayed sleep phase syndrome (DSPS), narcolepsy, night terror, sleep apnea, sleep walking);
- Has a current or previous diagnosis of any type of cancer;
- Has a diagnosis of an inflammatory, autoimmune, or chronic infectious disease (including rheumatoid arthritis, lupus, chronic liver disease, multiple sclerosis, fibromyalgia, inflammatory bowel disease, psoriasis, HIV);
- Has a serious cardiopulmonary medical condition (including cardiovascular disease, congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), restrictive lung disease, interstitial lung disease, asthma, acute or chronic bronchitis, cystic fibrosis, pneumonia, tuberculosis, pneumoconiosis, pulmonary hypertension, pulmonary embolism, pleural effusion, pneumothorax, obesity hypoventilation syndrome, neuromuscular lung disease).
- Self reports -well‖ level of English fluency and indicates a preference for an interpreter.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group
During the first 2 weeks, measurements (e.g.
biological markers and air monitoring) will be taken under usual conditions.
At the end of the initial two weeks, portable HEPA air purifiers (136) will be placed in the Intervention Group drivers' cars and the air monitoring and biological parameters will be repeated for another 2-week period, to determine changes in PM levels and physiological measurements as a result of this targeted intervention.
|
air purifiers to remove PM and volatile organic compounds will be placed in drivers cars
PM and biological measurements
PAH (Polycyclic Aromatic Hydrocarbon) will be assessed via urine sample collection of Urinary 1 hydroxy pyrene and particulate matter collected via Polyurethane Foam Filter (PUF) sampler
|
Experimental: Wait-list Control Group
During the first 2 weeks, measurements (e.g.
biological markers and air monitoring) will be taken under usual conditions.
The Wait-list Control Group drivers will not receive a HEPA air purifier at this time, but will also have the air monitoring and biological parameters repeated for another 2 weeks.
At the end of the 1 month period of measurements for both groups of drivers, the Wait-list drivers will then receive a HEPA air purifier, so that they may also potentially benefit from the intervention being tested in this study, but no further measurements will be taken.
|
air purifiers to remove PM and volatile organic compounds will be placed in drivers cars
PM and biological measurements
PAH (Polycyclic Aromatic Hydrocarbon) will be assessed via urine sample collection of Urinary 1 hydroxy pyrene and particulate matter collected via Polyurethane Foam Filter (PUF) sampler
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Collect Preliminary Data on In-vehicle Excess Particulate Matter (PM) Exposure
Time Frame: 2 years
|
monitor/report the PM levels as time-averaged sample (hourly averages) that will be monitored at work site and at homes across all groups
|
2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jennifer Leng, MD, MPH, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 14-247
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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