Risk ReductionSaVENCT03833713
Utilizing Text Messaging to Improve Vehicle Safety Among At-Risk Young Adults
A study testing SMS Dialogue and SMS Assessments in people with Risk Reduction, run by University of Pittsburgh at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Risk Reduction
- What is being tested?
- SMS Dialogue and SMS Assessments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Sep 2019to 22 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1) 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Pennsylvania Hospital Emergency Departments
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center Emergency Departments
Pittsburgh, Pennsylvania, 15261
About this study
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.
Read the 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.
- Conditions
- Risk Reduction
- Being tested
- SMS Dialogue, SMS Assessments
- Keywords
- text message, behavioral intervention, motor vehicle
- Medical subject headings
- Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS DialogueBehavioural
Once-weekly SMS dialogue sessions or micro-interventions and use behavior change techniques (BCTs) including self-monitoring with performance feedback and goal support
SMS AssessmentsBehavioural
Once-weekly SMS assessments of motor vehicle risks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: SMS Dialogue |
| SMS Assessments | Active comparator | Once-weekly SMS assessments related to their target risk behavior without receiving any feedback or goal support Receives: Behavioral: SMS Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seat Belt Use
Participant count reporting always using a seat belt over past 2 weeks
Measured: Week 8
Secondary outcomes (3)
Feasibility of Recruitment
Percentage of ED patients who screen positive
Measured: Baseline
Measure of Intervention Acceptability
Percentage of ED patients enrolled in the Intervention arm who complete at least 50% of the SMS assessments during the intervention period
Measured: 2 weeks to 8 weeks
Seat Belt Use
Participant count reporting always using a seat belt over past 2 weeks
Measured: Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start26 Sep 2019
- Primary completion22 Nov 2021
- Study completion22 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Risk ReductionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, 2-arm (intervention vs. control)
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Principal investigator, Maria Pacella, University of Pittsburgh
- Investigators
- Maria Pacella, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833713
- Sponsor's protocol ID
- STUDY20020035 (CC)
- Other IDs
- 693JJ91850017
- Acronym
- SaVE
- Status last verified
- Mar 2024
- First submitted
- 5 Feb 2019
- Last updated
- 9 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 36129713
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Text Messaging to Improve Vehicle Safety Among At-Risk Young Adults
- ClinicalTrials.gov ID
- NCT03833713
- Acronym / sponsor ID
- SaVE / STUDY20020035 (CC)
- Conditions
- Risk Reduction
- Keywords
- text message, behavioral intervention, motor vehicle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 22 Nov 2021 (actual)
- Study completion
- 22 Nov 2021 (actual)
- First posted
- 7 Feb 2019 (actual)
- Results
- Posted 9 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, 2-arm (intervention vs. control)
| Arm | Type | Receives |
|---|---|---|
| SMS Intervention | Experimental | Behavioral: SMS DialogueOnce-weekly automated SMS dialogue sessions or micro-interventions and use behavior change techniques including self-monitoring with performance feedback and goal support |
| SMS Assessments | Active comparator | Behavioral: SMS AssessmentsOnce-weekly SMS assessments related to their target risk behavior without receiving any feedback or goal support |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1) 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMS DialogueOnce-weekly SMS dialogue sessions or micro-interventions and use behavior change techniques (BCTs) including self-monitoring with performance feedback and goal support | Behavioural | SMS Intervention |
| SMS AssessmentsOnce-weekly SMS assessments of motor vehicle risks | Behavioural | SMS Assessments |
Primary outcome
Seat Belt Use
Time frame: Week 8
Participant count reporting always using a seat belt over past 2 weeks
3 secondary outcomes
Feasibility of Recruitment
Time frame: Baseline
Measure of Intervention Acceptability
Time frame: 2 weeks to 8 weeks
Seat Belt Use
Time frame: Week 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36129713Suffoletto 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Pacella, PhD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS Dialogue and SMS Assessments in people with Risk Reduction, run by University of Pittsburgh at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seat Belt Use (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03833713, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.