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

Risk Reduction Clinical Trial

— SaVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03833713
• Other study ID #: STUDY20020035 (CC)
• Secondary ID: 693JJ91850017
• Status: Completed
• Phase: N/A
• Start date: September 26, 2019
• Est. completion date: November 22, 2021

Study information

• Verified date: March 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 456
• Est. completion date: November 22, 2021
• Est. primary completion date: November 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Risk Reduction

Intervention

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
• SMS Assessments
Once-weekly SMS assessments of motor vehicle risks

Locations

Country	Name	City	State
United States	University of Pennsylvania Hospital Emergency Departments	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center Emergency Departments	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants who report a vehicle risk	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	Percentage of ED patients who screen positive and agree to enroll	Measure of feasibility	Baseline
Secondary	Percentage of ED patients enrolled in the Intervention arm who complete at least 50% of the SMS assessments during the intervention period	Measure of acceptability	2 weeks to 8 weeks
Secondary	Percentage of Subjects with Vehicle Risks	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