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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03833713
Recruitment Status : Completed
First Posted : February 7, 2019
Last Update Posted : March 9, 2022
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Maria Pacella, University of Pittsburgh

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 456 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 : September 26, 2019
Actual Primary Completion Date : November 22, 2021
Actual Study Completion Date : November 22, 2021
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Percentage of participants who report a vehicle risk [ Time Frame: 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 :
  1. Percentage of ED patients who screen positive and agree to enroll [ Time Frame: Baseline ]
    Measure of feasibility

  2. Percentage of ED patients enrolled in the Intervention arm who complete at least 50% of the SMS assessments during the intervention period [ Time Frame: 2 weeks to 8 weeks ]
    Measure of acceptability

  3. Percentage of Subjects with Vehicle Risks [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03833713


Locations
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United States, Pennsylvania
University of Pennsylvania Hospital Emergency Departments
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center Emergency Departments
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh
University of Pennsylvania
Investigators
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Principal Investigator: Maria Pacella, PhD University of Pittsburgh
  Study Documents (Full-Text)

Documents provided by Maria Pacella, University of Pittsburgh:
Informed Consent Form  [PDF] June 15, 2020

More Information
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Responsible Party: Maria Pacella, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03833713    
Other Study ID Numbers: STUDY20020035 (CC)
693JJ91850017 ( Other Grant/Funding Number: NHTSA )
First Posted: February 7, 2019    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Pacella, University of Pittsburgh:
text message
behavioral intervention
motor vehicle