Utilizing Text Messaging to Improve Vehicle Safety Among At-Risk Young Adults (SaVE)

March 7, 2022 updated by: Maria Pacella, University of Pittsburgh
The "Safe Vehicle Engagement (SaVE)" trials are 3 parallel randomized clinical trials that aim to determine the impact of text messaging (SMS) vehicle safety interventions vs. weekly SMS vehicle safety self-monitoring alone on seat belt use, distracted driving and drink driving among young adults identified in the emergency department (ED) with risky vehicle behaviors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators propose to conduct 3 related randomized, controlled, parallel group, assessor-blind, superiority trials of 6-week text message interventions vs. SMS vehicle safety self-monitoring in young adult participants with risky vehicle behaviors. A total of 500 adult participants will be enrolled: 300 into Cohort 1 (seat belt); 100 into Cohort 2 (distracted driving); 100 into Cohort 3 (drink driving). Each SMS intervention will be designed to target a single risk behavior. The study is powered to show a difference of 15% in the percentage of subjects reporting seat belt use at week 8. Other cohort trials (i.e. distracted driving, drink driving) and outcomes will be exploratory.

Study Type

Interventional

Enrollment (Actual)

456

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Hospital Emergency Departments
      • Pittsburgh, Pennsylvania, United States, 15261
        • University of Pittsburgh Medical Center Emergency Departments

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

1) Adult participant (age ≥ 18 years & ≤25 years)

  1. Cohort 1: Any vehicle trip in past 2 weeks where individual reports not using a seat belt
  2. Cohort 2: Any vehicle trip in past 2 weeks where individual reports phone was used to type while driving and car was moving
  3. Cohort 3: Any vehicle trip in past 2 weeks where individual reports driving a vehicle within 2 hours after consuming 2 or more drinks

Exclusion criteria:

  1. Member of a protected population (prisoner)
  2. Unable to provide informed consent
  3. No plan to drive and/or ride in a vehicle in the next month
  4. Non-English speaking
  5. No personal mobile phone or planning on changing phone in next 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SMS Intervention
Once-weekly automated SMS dialogue sessions or micro-interventions and use behavior change techniques including self-monitoring with performance feedback and goal support
Behavioral: SMS Dialogue
Once-weekly SMS dialogue sessions or micro-interventions and use behavior change techniques (BCTs) including self-monitoring with performance feedback and goal support
ACTIVE_COMPARATOR: SMS Assessments
Once-weekly SMS assessments related to their target risk behavior without receiving any feedback or goal support
Behavioral: SMS Assessments
Once-weekly SMS assessments of motor vehicle risks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants who report a vehicle risk
Time Frame: Week 8
Cohort 1: Any vehicle trip in past 2 weeks where individual reports not using a seat belt e. Cohort 2: Any vehicle trip in past 2 weeks where individual reports phone was used to type while driving and car was moving f. Cohort 3: Any vehicle trip in past 2 weeks where individual reports driving a vehicle within 2 hours after consuming 2 or more drinks
Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of ED patients who screen positive and agree to enroll
Time Frame: Baseline
Measure of feasibility
Baseline
Percentage of ED patients enrolled in the Intervention arm who complete at least 50% of the SMS assessments during the intervention period
Time Frame: 2 weeks to 8 weeks
Measure of acceptability
2 weeks to 8 weeks
Percentage of Subjects with Vehicle Risks
Time Frame: Week 14
Cohort 1: Any vehicle trip in past 2 weeks where individual reports not using a seat belt e. Cohort 2: Any vehicle trip in past 2 weeks where individual reports phone was used to type while driving and car was moving f. Cohort 3: Any vehicle trip in past 2 weeks where individual reports driving a vehicle within 2 hours after consuming 2 or more drinks
Week 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

University of Pennsylvania

Investigators

  • Principal Investigator: Maria Pacella, PhD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 26, 2019

Primary Completion (ACTUAL)

November 22, 2021

Study Completion (ACTUAL)

November 22, 2021

Study Registration Dates

First Submitted

February 5, 2019

First Submitted That Met QC Criteria

February 5, 2019

First Posted (ACTUAL)

February 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2022

Last Update Submitted That Met QC Criteria

March 7, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY20020035 (CC)
  • 693JJ91850017 (OTHER_GRANT: NHTSA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Procedures, including re-coding of key variables, will be put in place to allow for complete de-identification of the data. All relevant trial-related documents, including the protocol, data dictionary, and the main statistical code, will be shared along with the data. There will be no predetermined end date for the data sharing. Data will be available for any research purpose to all interested parties who have approval from an independent ethics review committee and who have a methodological sound proposal as determined by the steering committee of the current trial. Interested parties will be able to request the data by contacting the principal investigator.

IPD Sharing Time Frame

Six months after publication of main trial findings.

IPD Sharing Access Criteria

Data will be available for any research purpose to all interested parties who have approval from an independent ethics review committee and who have a methodological sound proposal as determined by the steering committee of the current trial.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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