<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03833713</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY20020035 (CC)</org_study_id>
    <secondary_id>693JJ91850017</secondary_id>
    <nct_id>NCT03833713</nct_id>
  </id_info>
  <brief_title>Utilizing Text Messaging to Improve Vehicle Safety Among At-Risk Young Adults</brief_title>
  <acronym>SaVE</acronym>
  <official_title>Utilizing Text Messaging to Improve Vehicle Safety Among At-Risk Young Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The &quot;Safe Vehicle Engagement (SaVE)&quot; trials are 3 parallel randomized clinical trials that&#xD;
      aim to determine the impact of text messaging (SMS) vehicle safety interventions vs. weekly&#xD;
      SMS vehicle safety self-monitoring alone on seat belt use, distracted driving and drink&#xD;
      driving among young adults identified in the emergency department (ED) with risky vehicle&#xD;
      behaviors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators propose to conduct 3 related randomized, controlled, parallel group,&#xD;
      assessor-blind, superiority trials of 6-week text message interventions vs. SMS vehicle&#xD;
      safety self-monitoring in young adult participants with risky vehicle behaviors. A total of&#xD;
      500 adult participants will be enrolled: 300 into Cohort 1 (seat belt); 100 into Cohort 2&#xD;
      (distracted driving); 100 into Cohort 3 (drink driving). Each SMS intervention will be&#xD;
      designed to target a single risk behavior. The study is powered to show a difference of 15%&#xD;
      in the percentage of subjects reporting seat belt use at week 8. Other cohort trials (i.e.&#xD;
      distracted driving, drink driving) and outcomes will be exploratory.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 26, 2019</start_date>
  <completion_date type="Actual">November 22, 2021</completion_date>
  <primary_completion_date type="Actual">November 22, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Prospective, randomized, 2-arm (intervention vs. control)</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of participants who report a vehicle risk</measure>
    <time_frame>Week 8</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of ED patients who screen positive and agree to enroll</measure>
    <time_frame>Baseline</time_frame>
    <description>Measure of feasibility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of ED patients enrolled in the Intervention arm who complete at least 50% of the SMS assessments during the intervention period</measure>
    <time_frame>2 weeks to 8 weeks</time_frame>
    <description>Measure of acceptability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects with Vehicle Risks</measure>
    <time_frame>Week 14</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">456</enrollment>
  <condition>Risk Reduction</condition>
  <arm_group>
    <arm_group_label>SMS Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Once-weekly automated SMS dialogue sessions or micro-interventions and use behavior change techniques including self-monitoring with performance feedback and goal support</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SMS Assessments</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Once-weekly SMS assessments related to their target risk behavior without receiving any feedback or goal support</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SMS Dialogue</intervention_name>
    <description>Once-weekly SMS dialogue sessions or micro-interventions and use behavior change techniques (BCTs) including self-monitoring with performance feedback and goal support</description>
    <arm_group_label>SMS Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SMS Assessments</intervention_name>
    <description>Once-weekly SMS assessments of motor vehicle risks</description>
    <arm_group_label>SMS Assessments</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        1) Adult participant (age ≥ 18 years &amp; ≤25 years)&#xD;
&#xD;
          1. Cohort 1: Any vehicle trip in past 2 weeks where individual reports not using a seat&#xD;
             belt&#xD;
&#xD;
          2. Cohort 2: Any vehicle trip in past 2 weeks where individual reports phone was used to&#xD;
             type while driving and car was moving&#xD;
&#xD;
          3. Cohort 3: Any vehicle trip in past 2 weeks where individual reports driving a vehicle&#xD;
             within 2 hours after consuming 2 or more drinks&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Member of a protected population (prisoner)&#xD;
&#xD;
          2. Unable to provide informed consent&#xD;
&#xD;
          3. No plan to drive and/or ride in a vehicle in the next month&#xD;
&#xD;
          4. Non-English speaking&#xD;
&#xD;
          5. No personal mobile phone or planning on changing phone in next 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Pacella, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pennsylvania Hospital Emergency Departments</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center Emergency Departments</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15261</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>March 7, 2022</last_update_submitted>
  <last_update_submitted_qc>March 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Maria Pacella</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>text message</keyword>
  <keyword>behavioral intervention</keyword>
  <keyword>motor vehicle</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_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.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Six months after publication of main trial findings.</ipd_time_frame>
    <ipd_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.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 15, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT03833713/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>May 4, 2023</submitted>
    <submission_canceled>May 8, 2023</submission_canceled>
    <submitted>June 30, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03833713
org study id: STUDY20020035 (CC)
secondary id: 693JJ91850017
nct id: NCT03833713
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, randomized, 2-arm (intervention vs. control)
primary purpose: Prevention
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of participants who report a vehicle risk
time frame: Week 8
description: 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
measure: Percentage of ED patients who screen positive and agree to enroll
time frame: Baseline
description: Measure of feasibility
measure: 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
description: Measure of acceptability
measure: Percentage of Subjects with Vehicle Risks
time frame: Week 14
description: 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
arm group label: SMS Intervention
arm group type: Experimental
description: Once-weekly automated SMS dialogue sessions or micro-interventions and use behavior change techniques including self-monitoring with performance feedback and goal support
arm group label: SMS Assessments
arm group type: Active Comparator
description: Once-weekly SMS assessments related to their target risk behavior without receiving any feedback or goal support
intervention type: Behavioral
intervention name: SMS Dialogue
description: Once-weekly SMS dialogue sessions or micro-interventions and use behavior change techniques (BCTs) including self-monitoring with performance feedback and goal support
arm group label: SMS Intervention
intervention type: Behavioral
intervention name: SMS Assessments
description: Once-weekly SMS assessments of motor vehicle risks
arm group label: SMS Assessments
criteria: 
gender: All
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: No
last name: Maria Pacella, PhD
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Maria Pacella
investigator title: Assistant Professor
sharing ipd: Yes
ipd 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.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Six months after publication of main trial findings.
ipd 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.
provided document: 
submitted: May 4, 2023
submission canceled: May 8, 2023
submitted: June 30, 2023