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

NCT ID: NCT03833713

Last Updated: 2024-08-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-26

Study Completion Date

2021-11-22

Brief Summary

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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

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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.

Conditions

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Risk Reduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomized, 2-arm (intervention vs. control)
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

SMS Dialogue

Intervention Type BEHAVIORAL

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 related to their target risk behavior without receiving any feedback or goal support

Group Type ACTIVE_COMPARATOR

SMS Assessments

Intervention Type BEHAVIORAL

Once-weekly SMS assessments of motor vehicle risks

Interventions

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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

Intervention Type BEHAVIORAL

SMS Assessments

Once-weekly SMS assessments of motor vehicle risks

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Maria Pacella

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Pacella, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pennsylvania Hospital Emergency Departments

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center Emergency Departments

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36129713 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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693JJ91850017

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY20020035 (CC)

Identifier Type: -

Identifier Source: org_study_id

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