Clinical trial NCT02381626: DRIIVE (Data and Research on Interventions to Improve the Vehicular Environment)
Official title: DRIIVE (Data and Research on Interventions to Improve the Vehicular Environment)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vehicular Environment
Keywords: HEPA filter
14-247
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: New York University
name: New York State Department of Health
name: The City College of New York
First posted: 2015-03-06
Enrollment: 39
Sex: MALE
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: DRIIVE (Data and Research on Interventions to Improve the Vehicular Environment) is a community-engaged translational pilot project that will utilize a three parallel arm design to obtain preliminary data on associations between Particulate Matter (PM)/air pollution and physiologic measurements and biomarkers in taxi drivers, and to determine the impact of a HEPA filter (to remove PM and volatile organic compounds) intervention on such physiologic measurements and biomarkers. DRIIVE is funded by the New York State Department of Health Empire Clinical Research Investigator Program (ECRIP), which trains physicians in clinical research in New York. Drivers will be randomized to one of two groups: Intervention or Wait-list Control. In total, two groups of 14 participants in each group will be recruited: 1) Wait List Control group, who will receive a HEPA filter at the end of the 1 month participation period, and 2) Intervention group, who will receive a HEPA filter two weeks into their participation period. The project will be completed within a 2 year timeframe.

Eligibility criteria: 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.

Primary outcomes:
measure: Collect Preliminary Data on In-vehicle Excess Particulate Matter (PM) Exposure
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jennifer Leng, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: