Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 693JJ91850017 | Other Grant/Funding Number | NHTSA |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| SMS Assessments | Active Comparator | Once-weekly SMS assessments related to their target risk behavior without receiving any feedback or goal support |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMS Dialogue | Behavioral | Once-weekly SMS dialogue sessions or micro-interventions and use behavior change techniques (BCTs) including self-monitoring with performance feedback and goal support |
| Measure | Description | Time Frame |
|---|---|---|
| Seat Belt Use | Participant count reporting always using a seat belt over past 2 weeks | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Recruitment | Percentage of ED patients who screen positive | 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 |
Not provided
Inclusion criteria:
1) Adult participant (age ≥ 18 years & ≤25 years)
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Maria Pacella, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania Hospital Emergency Departments | Philadelphia | Pennsylvania | 19104 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36129713 | Derived | 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. |
Not provided
Not provided
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.
Six months after publication of main trial findings.
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.
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 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 |
| FG001 | SMS Assessments | Once-weekly SMS assessments related to their target risk behavior without receiving any feedback or goal support SMS Assessments: Once-weekly SMS assessments of motor vehicle risks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Seat Belt Use | Participant count reporting always using a seat belt over past 2 weeks | 158 participants completed the 8-week follow-up and thus were included in outcome analyses. | Posted | Count of Participants | Participants | Week 8 |
|
12 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Suffoletto | Stanford University | 4129016892 | suffbp@stanford.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2019 | Mar 4, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 15, 2020 | Mar 4, 2024 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D040242 | Risk Reduction Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
Prospective, randomized, 2-arm (intervention vs. control)
Not provided
Not provided
Not provided
| SMS Assessments | Behavioral | Once-weekly SMS assessments of motor vehicle risks |
|
| 2 weeks to 8 weeks |
| Seat Belt Use | Participant count reporting always using a seat belt over past 2 weeks | Week 14 |
| University of Pittsburgh Medical Center Emergency Departments |
| Pittsburgh |
| Pennsylvania |
| 15261 |
| United States |
| BG001 |
| SMS Assessments |
Once-weekly SMS assessments related to their target risk behavior without receiving any feedback or goal support SMS Assessments: Once-weekly SMS assessments of motor vehicle risks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Once-weekly SMS assessments related to their target risk behavior without receiving any feedback or goal support
SMS Assessments: Once-weekly SMS assessments of motor vehicle risks
|
|
| Secondary | Feasibility of Recruitment | Percentage of ED patients who screen positive | Reported less than always seat belt use in the past 2 weeks either as a driver or passenger and met other enrollment criteria | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 2 weeks to 8 weeks |
|
|
|
| Secondary | Seat Belt Use | Participant count reporting always using a seat belt over past 2 weeks | 140 participants completed the 14-week follow-up and thus were included in outcome analyses. | Posted | Count of Participants | Participants | Week 14 |
|
|
|
| 0 |
| 110 |
| 0 |
| 110 |
| 0 |
| 110 |
| EG001 | SMS Assessments | Once-weekly SMS assessments related to their target risk behavior without receiving any feedback or goal support SMS Assessments: Once-weekly SMS assessments of motor vehicle risks | 0 | 108 | 0 | 108 | 0 | 108 |
Not provided
Not provided