Trial Outcomes & Findings for DRIIVE (Data and Research on Interventions to Improve the Vehicular Environment) (NCT NCT02381626)
NCT ID: NCT02381626
Last Updated: 2021-10-05
Results Overview
monitor/report the PM levels as time-averaged sample (hourly averages) that will be monitored at work site and at homes across all groups
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
2 years
Results posted on
2021-10-05
Participant Flow
Participant milestones
| Measure |
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.
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
|
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.
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 non-driver (peer is matched to driver assigned to the HEPA filter intervention group)
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
6
|
|
Overall Study
COMPLETED
|
17
|
16
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
DRIIVE (Data and Research on Interventions to Improve the Vehicular Environment)
Baseline characteristics by cohort
| Measure |
Intervention Group
n=17 Participants
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
|
Wait-list Control Group
n=16 Participants
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
n=6 Participants
Peer non-driver (peer is matched to driver assigned to the HEPA filter intervention group)
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.5 years
n=99 Participants
|
49.5 years
n=107 Participants
|
48.7 years
n=206 Participants
|
48.1 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
39 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
39 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Data were not collected
monitor/report the PM levels as time-averaged sample (hourly averages) that will be monitored at work site and at homes across all groups
Outcome measures
Outcome data not reported
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wait-list Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Peer Non-driver
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jennifer Leng, MD, MPH
Memorial Sloan Kettering Cancer Center
Phone: 646-888-8057
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place