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Completed

NCT Number: NCT03833713

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

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.

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Key information

Conditions

Risk Reduction Behavior Risk Reduction Behavior

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania Hospital Emergency Departments, Philadelphia, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult participant (age ≥ 18 years & ≤25 years)
  • Cohort 1: Any vehicle trip in past 2 weeks where individual reports not using a seat belt
  • Cohort 2: Any vehicle trip in past 2 weeks where individual reports phone was used to type while driving and car was moving
  • 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

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

Treatment and study plan

SMS Dialogue

Behavioral

Once-weekly SMS dialogue sessions or micro-interventions and use behavior change techniques (BCTs) including self-monitoring with performance feedback and goal support

SMS Assessments

Behavioral

Once-weekly SMS assessments of motor vehicle risks

Primary outcomes

  1. Seat Belt Use

    Time frame: Week 8

    Participant count reporting always using a seat belt over past 2 weeks

Secondary outcomes

  1. Feasibility of Recruitment

    Time frame: Baseline

    Percentage of ED patients who screen positive

  2. Measure of Intervention Acceptability

    Time frame: 2 weeks to 8 weeks

    Percentage of ED patients enrolled in the Intervention arm who complete at least 50% of the SMS assessments during the intervention period

  3. Seat Belt Use

    Time frame: Week 14

    Participant count reporting always using a seat belt over past 2 weeks

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • University of Pennsylvania

Registry information

Acronym: SaVE

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 7, 2019
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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