Clinical trial NCT03833713: Utilizing Text Messaging to Improve Vehicle Safety Among At-Risk Young Adults
Official title: Utilizing Text Messaging to Improve Vehicle Safety Among At-Risk Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Reduction
Keywords: text message
behavioral intervention
motor vehicle
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
First posted: 2019-02-07
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, 2-arm (intervention vs. control)
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Seat Belt Use
timeFrame: Week 8
Secondary outcomes:
measure: Feasibility of Recruitment
timeFrame: Baseline
measure: Measure of Intervention Acceptability
timeFrame: 2 weeks to 8 weeks
measure: Seat Belt Use
timeFrame: Week 14
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Hospital Emergency Departments
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Emergency Departments
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Maria Pacella, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suffoletto B, Pacella-LaBarbara ML, Huber J, Delgado MK, McDonald C. Effectiveness of a Text Message Intervention Promoting Seat Belt Use Among Young Adults: A Randomized Clinical Trial. JAMA Netw Open. 2022 Sep 1;5(9):e2231616. doi: 10.1001/jamanetworkopen.2022.31616.