Trial Outcomes & Findings for Way to Safety Cellphone Blocking (NCT NCT02416713)

NCT ID: NCT02416713

Last Updated: 2019-02-28

Results Overview

Change in number of phone unlocks per hour of drive time between intervention period (last 3 weeks) vs. baseline period (last 3 weeks)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

6 weeks

Results posted on

2019-02-28

Participant Flow

Participant milestones

Participant milestones
Measure
Education Only (Control)
The Cellcontrol DriveID device will run completely in the background with no observable changes to cellphone functions while driving. During Week Four, participants will be presented educational materials on the dangers of distracted driving. Education Only: No active intervention, educational materials will be provided
Opt-in Blocking
Participants will have to initiate Cellcontrol DriveID device when entering the vehicle; the blocking settings will be pre-set to block all calls and text messages when the car is in motion. Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts.
Opt-out Blocking
Cellcontrol DriveID device will automatically turn on when the teen begins driving and will be pre-set to block all calls and text messages when the car is in motion. Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts.
Opt-out Blocking With Notification
Cellcontrol DriveID device will automatically turn on when the teen begins driving and will be pre-set to block all calls and text messages when the car is in motion. If a participant overrides the blocking function, an email will be sent to a parent/guardian. Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts.
Overall Study
STARTED
8
9
8
10
Overall Study
COMPLETED
8
9
8
10
Overall Study
NOT COMPLETED
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Way to Safety Cellphone Blocking

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Education Only (Control)
n=8 Participants
The Cellcontrol DriveID device will run completely in the background with no observable changes to cellphone functions while driving. During Week Four, participants will be presented educational materials on the dangers of distracted driving. Education Only: No active intervention, educational materials will be provided
Opt-in Blocking
n=9 Participants
Participants will have to initiate Cellcontrol DriveID device when entering the vehicle; the blocking settings will be pre-set to block all calls and text messages when the car is in motion. Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts.
Opt-out Blocking
n=8 Participants
Cellcontrol DriveID device will automatically turn on when the teen begins driving and will be pre-set to block all calls and text messages when the car is in motion. Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts.
Opt-out Blocking With Notification
n=10 Participants
Cellcontrol DriveID device will automatically turn on when the teen begins driving and will be pre-set to block all calls and text messages when the car is in motion. If a participant overrides the blocking function, an email will be sent to a parent/guardian. Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts.
Total
n=35 Participants
Total of all reporting groups
Age, Categorical
<=18 years
8 Participants
n=99 Participants
9 Participants
n=107 Participants
8 Participants
n=206 Participants
10 Participants
n=7 Participants
35 Participants
n=31 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
Sex: Female, Male
Female
6 Participants
n=99 Participants
7 Participants
n=107 Participants
6 Participants
n=206 Participants
6 Participants
n=7 Participants
25 Participants
n=31 Participants
Sex: Female, Male
Male
2 Participants
n=99 Participants
2 Participants
n=107 Participants
2 Participants
n=206 Participants
4 Participants
n=7 Participants
10 Participants
n=31 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
1 Participants
n=7 Participants
1 Participants
n=31 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
8 Participants
n=99 Participants
9 Participants
n=107 Participants
8 Participants
n=206 Participants
9 Participants
n=7 Participants
34 Participants
n=31 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
0 Participants
n=31 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
0 Participants
n=31 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
1 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
1 Participants
n=31 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
0 Participants
n=31 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
1 Participants
n=31 Participants
Race (NIH/OMB)
White
6 Participants
n=99 Participants
7 Participants
n=107 Participants
8 Participants
n=206 Participants
9 Participants
n=7 Participants
30 Participants
n=31 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=99 Participants
1 Participants
n=107 Participants
0 Participants
n=206 Participants
1 Participants
n=7 Participants
3 Participants
n=31 Participants
Race (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
0 Participants
n=31 Participants
Region of Enrollment
United States
8 Participants
n=99 Participants
9 Participants
n=107 Participants
8 Participants
n=206 Participants
10 Participants
n=7 Participants
35 Participants
n=31 Participants

PRIMARY outcome

Timeframe: 6 weeks

Change in number of phone unlocks per hour of drive time between intervention period (last 3 weeks) vs. baseline period (last 3 weeks)

Outcome measures

Outcome measures
Measure
Education Only (Control)
n=8 Participants
The Cellcontrol DriveID device will run completely in the background with no observable changes to cellphone functions while driving. During Week Four, participants will be presented educational materials on the dangers of distracted driving. Education Only: No active intervention, educational materials will be provided
Opt-in Blocking
n=9 Participants
Participants will have to initiate Cellcontrol DriveID device when entering the vehicle; the blocking settings will be pre-set to block all calls and text messages when the car is in motion. Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts.
Opt-out Blocking
n=8 Participants
Cellcontrol DriveID device will automatically turn on when the teen begins driving and will be pre-set to block all calls and text messages when the car is in motion. Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts.
Opt-out Blocking With Notification
n=10 Participants
Cellcontrol DriveID device will automatically turn on when the teen begins driving and will be pre-set to block all calls and text messages when the car is in motion. If a participant overrides the blocking function, an email will be sent to a parent/guardian. Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts.
Change in Frequency of Cellphone Unlocks
0.26 Phone unlocks per hour
Interval -0.52 to 1.04
0.52 Phone unlocks per hour
Interval -0.28 to 1.33
-0.95 Phone unlocks per hour
Interval -3.68 to 1.79
1.08 Phone unlocks per hour
Interval -1.62 to 3.78

Adverse Events

Education Only (Control)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Opt-in Blocking

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Opt-out Blocking

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Opt-out Blocking With Notification

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. M. Kit Delgado

University of Pennsylvania

Phone: 215-746-8256

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place