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

Sponsor

University of Pittsburgh (Other)

Overall Status

Completed

CT.gov ID

NCT03833713

Collaborator

University of Pennsylvania (Other)

456

Enrollment

Locations

Arms

25.9

Actual Duration (Months)

228

Patients Per Site

8.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Risk Reduction	Behavioral: SMS Dialogue Behavioral: SMS Assessments	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

456 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective, randomized, 2-arm (intervention vs. control)Prospective, randomized, 2-arm (intervention vs. control)

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 26, 2019

Actual Primary Completion Date :

Nov 22, 2021

Actual Study Completion Date :

Nov 22, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Percentage of participants who report a vehicle risk [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

Secondary Outcome Measures

Percentage of ED patients who screen positive and agree to enroll [Baseline]
Measure of feasibility
Percentage of ED patients enrolled in the Intervention arm who complete at least 50% of the SMS assessments during the intervention period [2 weeks to 8 weeks]
Measure of acceptability
Percentage of Subjects with Vehicle Risks [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania Hospital Emergency Departments	Philadelphia	Pennsylvania	United States	19104
2	University of Pittsburgh Medical Center Emergency Departments	Pittsburgh	Pennsylvania	United States	15261

Sponsors and Collaborators

University of Pittsburgh
University of Pennsylvania

Investigators

Principal Investigator: Maria Pacella, PhD, University of Pittsburgh

Study Documents (Full-Text)

Informed Consent Form - Jun 15, 2020

More Information

Publications

None provided.

Responsible Party:

Maria Pacella, Assistant Professor, University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT03833713

Other Study ID Numbers:

STUDY20020035 (CC)
693JJ91850017

First Posted:

Feb 7, 2019

Last Update Posted:

Mar 9, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Maria Pacella, Assistant Professor, University of Pittsburgh

text message

behavioral intervention

motor vehicle

Study Results

No Results Posted as of Mar 9, 2022