DRIIVE (Data and Research on Interventions to Improve the Vehicular Environment)

• Sponsor: Memorial Sloan Kettering Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02381626
• Collaborator: New York University (Other), New York State Department of Health (Other), The City College of New York (Other)
• Enrollment: 39
• Location: 1
• Arms: 2
• Duration (Months): 70.6
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vehicular Environment	Device: HEPA air purifier; Behavioral: questionnaires; Other: Log-book; Other: Urine sample	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: DRIIVE (Data and Research on Interventions to Improve the Vehicular Environment)
• Study Start Date: Dec 1, 2014
• Actual Primary Completion Date: Oct 18, 2020
• Actual Study Completion Date: Oct 18, 2020

Arms and Interventions

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.	Device: HEPA air purifier; air purifiers to remove PM and volatile organic compounds will be placed in drivers cars; Behavioral: questionnaires; Other: Log-book; PM and biological measurements; Other: Urine sample; 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.	Device: HEPA air purifier; air purifiers to remove PM and volatile organic compounds will be placed in drivers cars; Behavioral: questionnaires; Other: Log-book; PM and biological measurements; Other: Urine sample; 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

Outcome Measures

Primary Outcome Measures

1. Collect Preliminary Data on In-vehicle Excess Particulate Matter (PM) Exposure [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 90 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065

Sponsors and Collaborators

• Memorial Sloan Kettering Cancer Center
• New York University
• New York State Department of Health
• The City College of New York

Investigators

• Principal Investigator: Jennifer Leng, MD, MPH, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 20, 2017

More Information

Additional Information:

• Memorial Sloan Kettering Cancer Center

Publications

None provided.

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT02381626
• Other Study ID Numbers: 14-247
• First Posted: Mar 6, 2015
• Last Update Posted: Oct 5, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by Memorial Sloan Kettering Cancer Center: HEPA filter; 14-247

Study Results

Participant Flow

Arm/Group Title	Intervention Group	Wait-list Control Group	Peer Non-driver
Arm/Group Description	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. HEPA air purifier: air purifiers to remove PM and volatile organic compounds will be placed in drivers cars questionnaires Log-book: PM and biological measurements Urine sample: 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	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. HEPA air purifier: air purifiers to remove PM and volatile organic compounds will be placed in drivers cars questionnaires Log-book: PM and biological measurements Urine sample: 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	Peer non-driver (peer is matched to driver assigned to the HEPA filter intervention group)
Period Title: Overall Study
STARTED	17	16	6
COMPLETED	17	16	6
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Intervention Group	Wait-list Control Group	Peer Non-driver	Total
Arm/Group Description	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. HEPA air purifier: air purifiers to remove PM and volatile organic compounds will be placed in drivers cars questionnaires Log-book: PM and biological measurements Urine sample: 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	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. HEPA air purifier: air purifiers to remove PM and volatile organic compounds will be placed in drivers cars questionnaires Log-book: PM and biological measurements Urine sample: 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	Peer non-driver (peer is matched to driver assigned to the HEPA filter intervention group)	Total of all reporting groups
Overall Participants	17	16	6	39
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	46.5	49.5	48.7	48.1
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%
Male	17 100%	16 100%	6 100%	39 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 5.9%	3 18.8%	0 0%	4 10.3%
Not Hispanic or Latino	16 94.1%	13 81.3%	6 100%	35 89.7%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	2 11.8%	2 12.5%	0 0%	4 10.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	12 70.6%	11 68.8%	6 100%	29 74.4%
White	2 11.8%	1 6.3%	0 0%	3 7.7%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	1 5.9%	2 12.5%	0 0%	3 7.7%
Region of Enrollment (Count of Participants)
United States	17 100%	16 100%	6 100%	39 100%

Outcome Measures

1. Primary Outcome

Title	Collect Preliminary Data on In-vehicle Excess Particulate Matter (PM) Exposure
Description	monitor/report the PM levels as time-averaged sample (hourly averages) that will be monitored at work site and at homes across all groups
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	Intervention Group	Wait-list Control Group	Peer Non-driver
Arm/Group Description	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. HEPA air purifier: air purifiers to remove PM and volatile organic compounds will be placed in drivers cars questionnaires Log-book: PM and biological measurements Urine sample: 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	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. HEPA air purifier: air purifiers to remove PM and volatile organic compounds will be placed in drivers cars questionnaires Log-book: PM and biological measurements Urine sample: 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	Peer non-driver (peer is matched to driver assigned to the HEPA filter intervention group)
Measure Participants	0	0	0

Adverse Events

Time Frame	1 year
Arm/Group Title	Intervention Group		Wait-list Control Group		Peer Non-driver
Arm/Group Description	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. HEPA air purifier: air purifiers to remove PM and volatile organic compounds will be placed in drivers cars questionnaires Log-book: PM and biological measurements Urine sample: 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		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. HEPA air purifier: air purifiers to remove PM and volatile organic compounds will be placed in drivers cars questionnaires Log-book: PM and biological measurements Urine sample: 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		Peer non-driver (peer is matched to driver assigned to the HEPA filter intervention group)
All Cause Mortality
	Intervention Group		Wait-list Control Group		Peer Non-driver
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/16 (0%)		0/6 (0%)
Serious Adverse Events
	Intervention Group		Wait-list Control Group		Peer Non-driver
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/16 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Intervention Group		Wait-list Control Group		Peer Non-driver
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/16 (0%)		0/6 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.