- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06101251
A Randomized Field Trial of Smartphone-based Feedback to Encourage Safe Driving
A Randomized Field Trial of Smartphone-based Feedback Designed to Encourage Safe Driving: Comparing Focused and Self-chosen Goals to Standard UBI Messaging
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years of age or older
- Has an Apple or Android smartphone (iPhone iOS 12 or later or Android OS 7 or later)
- Drives at least 2 days per week
- English reading ability
- Passes an attention check
- Provides valid email address, cell number, name, address, and date of birth
Exclusion Criteria:
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control
Participants will have the Way to Drive app monitoring in the background throughout the intervention period for overall driving score, handheld phone use, speeding, hard braking, and fast acceleration. They will not receive feedback, driving tips or UBI-like behavioral incentives. Participants will also receive payment or non-adherence messages as needed for having the app functioning. |
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Active Comparator: Standard Feedback + UBI-like Behavioral Incentive
Participants will have the Way to Drive app monitoring in the background, and will receive payment or non-adherence messages as needed, but will also receive, Standard Feedback, Study Dashboard, Driving Tips, and UBI-like Behavioral Incentive
|
Each week participants will receive a safe driving tip for one of the four behaviors via text message.
Each week participants will receive a text message showing their overall driving score (out of 100) and subscores for distraction, hard braking, fast acceleration, and speeding (all running averages).
The scoreboard will indicate whether their scores have gone up, down, or stayed the same.
The message will include a link to a dashboard.
By clicking the link in the feedback text, they will be able to view a weekly dashboard that provides detailed information about their baseline, best, last, and average scores for each of the four behaviors, plus descriptions of the four behaviors.
At the end of the 12-week intervention period, their overall driving score will be translated into a $0-$100 reward amount.
For example, a participant with an overall driving score of 84 at the end of the intervention period would receive $84 in compensation.
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Active Comparator: Assigned Goal with UBI-like Behavioral Incentive
Participants will have the Way to Drive app monitoring in the background, and will receive payment or non-adherence messages as needed, but will also receive Assigned Focus Area Feedback, Driving Tips, a Study Dashboard, and UBI-like Behavioral Incentive
|
Each week participants will receive a safe driving tip for one of the four behaviors via text message.
At the end of the 12-week intervention period, their overall driving score will be translated into a $0-$100 reward amount.
For example, a participant with an overall driving score of 84 at the end of the intervention period would receive $84 in compensation.
Same as standard study dashboard, except participants will see at the top of the dashboard how well they are doing relative to their weekly goals.
Each week feedback will focus the participant's attention on the driving behavior with the greatest opportunity for improvement based on their baseline driving behavior.
Participants will be assigned a goal for the week of a score 5 points (3 points in the case of Driver Focus) better than their baseline for that area.
If they meet the goal, they will be given a new goal 5 points higher; if they fall short, they will be asked to try for the same goal again.
If they improve sufficiently-or if their improvement stalls out-they will be assigned a new behavior to focus on.
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Active Comparator: Self-Chosen Goal with UBI-like Behavioral Incentive
Participants will have the Way to Drive app monitoring in the background, and will receive payment or non-adherence messages as needed, but will also receive Self-Chosen Focus Area Feedback, Driving Tips, Study Dashboard, and UBI-like Behavioral Incentive.
|
Each week participants will receive a safe driving tip for one of the four behaviors via text message.
By clicking the link in the feedback text, they will be able to view a weekly dashboard that provides detailed information about their baseline, best, last, and average scores for each of the four behaviors, plus descriptions of the four behaviors.
At the end of the 12-week intervention period, their overall driving score will be translated into a $0-$100 reward amount.
For example, a participant with an overall driving score of 84 at the end of the intervention period would receive $84 in compensation.
Participants will be asked to select which driving behavior they want to focus on improving, and to set a goal for the week that is above their baseline score.
If they meet the goal, they will be asked to set a new, higher goal; if they fall short, they will be asked to try for the same goal again.
If they improve sufficiently-or if their improvement stalls out-they will be asked if they want to focus on a new behavior.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Driving Score
Time Frame: 12 weeks of the intervention period + separate analysis of 6 week post intervention.
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This is the mean of the four behavior scores for the intervention period (and, in a follow-up analysis of effect sustainability, the post-intervention period).
Scores can range from 0 -100, 100 being the safest driving score.
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12 weeks of the intervention period + separate analysis of 6 week post intervention.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Distraction score
Time Frame: 12 weeks of the intervention period + separate analysis of 6 week post intervention.
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A proprietary CMT score based on participant phone use-especially handheld phone use-while driving on a scale of 0-100, 100 being no phone use while driving (safest).
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12 weeks of the intervention period + separate analysis of 6 week post intervention.
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Speeding score
Time Frame: 12 weeks of the intervention period + separate analysis of 6 week post intervention.
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A proprietary CMT score based on the amount of time the participant drove over the speed limit on a scale from 0 -100, 100 being no incidences of driving over the speed limit.
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12 weeks of the intervention period + separate analysis of 6 week post intervention.
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Braking score
Time Frame: 12 weeks of the intervention period + separate analysis of 6 week post intervention.
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A proprietary CMT score based on the frequency of a participant's hard brakes on a scale of 0-100, 100 meaning no hard brakes.
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12 weeks of the intervention period + separate analysis of 6 week post intervention.
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Acceleration Score
Time Frame: 12 weeks of the intervention period + separate analysis of 6 week post intervention.
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A proprietary CMT score based on the frequency of a participant's fast accelerations on a scale of 0-100.
100, being no fast accelerations.
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12 weeks of the intervention period + separate analysis of 6 week post intervention.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Handheld phone use per hour of driving
Time Frame: 12 weeks of the intervention period + separate analysis of 6 week post intervention.
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This is a composite outcome that measures the proportion of total trip time in which the driver is engaged in handheld phone call use or non-call handheld use (e.g.
texting, swiping, and typing), as measured by the Way to Drive app.
Several studies (e.g.
Klauer, NEJM, 2014) have demonstrated the association between handheld phone use (e.g., reaching for phone, typing, swiping, dialing) and increased crash risk.
This outcome is also known as the active phone use percentage.
Passive phone use (e.g.
phone is streaming GPS navigation directions or music without any typing, swiping, or holding of the phone) is not included in this outcome.
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12 weeks of the intervention period + separate analysis of 6 week post intervention.
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Disabled SMS messaging
Time Frame: 18 weeks of the study (6 - week baseline; 12- week intervention period)
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If a participant texts "stop" or "bye" to stop receiving our intervention text messages, this could indicate unacceptability of push notification interventions.
This will be measured as a binary score, where participants that text "stop" or "bye" will be marked as 1, and those that do not will be marked as 0.
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18 weeks of the study (6 - week baseline; 12- week intervention period)
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Unenrolled
Time Frame: 18 weeks of the study (6 - week baseline; 12- week intervention period)
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If a participant asks to be unenrolled, this is an even stronger indicator of unacceptability.
This will be measured as a binary score, where 1 means the participant was unenrolled before the end of the intervention period, and 0 means they were not.
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18 weeks of the study (6 - week baseline; 12- week intervention period)
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Net Promoter Score (NPS)
Time Frame: At 24 weeks.
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This will be derived for each arm based on a 1-item question on a scale of 0 -10, 0 bring not at all likely to recommend the program, and 10 being extremely likely.
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At 24 weeks.
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4-item acceptability scale
Time Frame: At 24 weeks.
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This will be a 4-item acceptability scale administered in the exit survey.
For each participant the mean of the 4 items will be calculated for an overall acceptability score ranging from 1-5 (5 is the best).
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At 24 weeks.
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Intervention helpfulness.
Time Frame: At 24 weeks.
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Intervention arm participants will be asked to rate the helpfulness of each of the 4 intervention components (SMS feedback, weekly dashboard, SMS tips, $100 incentive), each on a scale of 1 (not at all) to 5 (extremely), with an option to indicate they did not see or were not aware of the intervention component.
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At 24 weeks.
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Hard braking events per 100 miles of driving
Time Frame: 12 weeks of the intervention period + separate analysis of 6 week post intervention.
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Number of hard braking evens per 100 miles of driving
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12 weeks of the intervention period + separate analysis of 6 week post intervention.
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Minutes of speeding per hour of driving.
Time Frame: 12 weeks of the intervention period + separate analysis of 6 week post intervention.
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Based on duration of speeding events detected by the app.
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12 weeks of the intervention period + separate analysis of 6 week post intervention.
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Fast acceleration events per 100 miles of driving.
Time Frame: 12 weeks of the intervention period + separate analysis of 6 week post intervention.
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Number of fast acceleration events per 100 miles of driving.
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12 weeks of the intervention period + separate analysis of 6 week post intervention.
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Overall riskiness metric
Time Frame: 12 weeks of the intervention period + separate analysis of 6 week post intervention.
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This is a composite measure of the underlying driving metrics for the four behaviors of interest.
For each behavior a z-score will be computed for each participant and take the mean of these four z-scores to get their overall riskiness.
This will be done for both the intervention period and the post-intervention period.
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12 weeks of the intervention period + separate analysis of 6 week post intervention.
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
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
- 853761
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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