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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03833713
Other study ID # STUDY20020035 (CC)
Secondary ID 693JJ91850017
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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