NCT03833713

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

September 26, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2021

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

August 9, 2024

Completed
Last Updated

August 9, 2024

Status Verified

March 1, 2024

Enrollment Period

2.2 years

First QC Date

February 5, 2019

Results QC Date

May 4, 2023

Last Update Submit

March 5, 2024

Conditions

Keywords

text messagebehavioral interventionmotor vehicle

Outcome Measures

Primary Outcomes (1)

  • Seat Belt Use

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

    Week 8

Secondary Outcomes (3)

  • Feasibility of Recruitment

    Baseline

  • Measure of Intervention Acceptability

    2 weeks to 8 weeks

  • Seat Belt Use

    Week 14

Study Arms (2)

SMS Intervention

EXPERIMENTAL

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

SMS Assessments

ACTIVE COMPARATOR

Once-weekly SMS assessments related to their target risk behavior without receiving any feedback or goal support

Behavioral: SMS Assessments

Interventions

SMS DialogueBEHAVIORAL

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

SMS Intervention
SMS AssessmentsBEHAVIORAL

Once-weekly SMS assessments of motor vehicle risks

SMS Assessments

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \) 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Pennsylvania Hospital Emergency Departments

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center Emergency Departments

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Brian Suffoletto
Organization
Stanford University

Study Officials

  • Maria Pacella, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Prospective, randomized, 2-arm (intervention vs. control)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 5, 2019

First Posted

February 7, 2019

Study Start

September 26, 2019

Primary Completion

November 22, 2021

Study Completion

November 22, 2021

Last Updated

August 9, 2024

Results First Posted

August 9, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

Procedures, including re-coding of key variables, will be put in place to allow for complete de-identification of the data. All relevant trial-related documents, including the protocol, data dictionary, and the main statistical code, will be shared along with the data. There will be no predetermined end date for the data sharing. Data will be available for any research purpose to all interested parties who have approval from an independent ethics review committee and who have a methodological sound proposal as determined by the steering committee of the current trial. Interested parties will be able to request the data by contacting the principal investigator.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Six months after publication of main trial findings.
Access Criteria
Data will be available for any research purpose to all interested parties who have approval from an independent ethics review committee and who have a methodological sound proposal as determined by the steering committee of the current trial.

Locations