NCT03417752

Brief Summary

This pilot study seeks to determine if exposure to the firearm safety public service announcement (PSA) developed by the U.S. Department of Veterans Affairs (VA) is associated with changes in related beliefs and safe storage practices. Participants are randomly assigned to message exposure or control conditions. Data from this project will inform injury prevention outreach efforts targeted towards Veteran populations.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
474

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
6 months until next milestone

Results Posted

Study results publicly available

August 19, 2020

Completed
Last Updated

August 19, 2020

Status Verified

August 1, 2020

Enrollment Period

4.3 years

First QC Date

January 25, 2018

Results QC Date

July 14, 2020

Last Update Submit

August 7, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Self-reported Injury Prevention Belief

    Number of participants with self-reported response to belief that "safe storage of household firearms is effective for reducing injury or death."

    baseline

  • Number of Participants With Self-reported Injury Prevention Belief

    Number of participants with self-reported response to belief that "safe storage of household firearms is effective for reducing injury or death."

    3 weeks post-baseline

Secondary Outcomes (2)

  • Number of Participants Who Self-reported Firearm Storage Behavior at Baseline

    baseline

  • Number of Participants Who Self-reported Firearm Storage Behavior at Exit

    3 weeks post-baseline

Study Arms (3)

Exposure to firearm safety Public Service Announcement (PSA)

EXPERIMENTAL

Exposure to the firearm safety PSA (approx. 2.5 minutes long) once per week for 3 weeks.

Other: Exposure to firearm safety PSA

Exposure to a mix of PSAs

EXPERIMENTAL

Exposure to a general health promotion video (approx. 2 minutes long) 1 week post-randomization followed by exposure to firearm safety PSA at 2- and 3-weeks post-randomization.

Other: Exposure to firearm safety PSAOther: Exposure to health promotion PSA

Active control

ACTIVE COMPARATOR

Exposure to the general health promotion video once per week for 3 weeks.

Other: Exposure to health promotion PSA

Interventions

Exposed to firearm safety PSA

Exposure to a mix of PSAsExposure to firearm safety Public Service Announcement (PSA)

Exposed to general health promotion PSA

Active controlExposure to a mix of PSAs

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veterans of all gender/sex, race/ethnicities
  • Living in United States
  • Fluent in English language
  • Capable of understanding the goals of the study
  • Possess computer/internet access

You may not qualify if:

  • Not a U.S. Veteran living in the United States
  • Determined to be cognitively impaired
  • Currently institutionalized (e.g., hospitalized; incarcerated, etc.)
  • Do not possess computer/internet access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Wounds and Injuries

Results Point of Contact

Title
Elizabeth Karras, PhD
Organization
VA Center of Excellence for Suicide Prevention

Study Officials

  • Elizabeth Karras, PhD

    VA Center of Excellence for Suicide Prevention

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Health Science Specialist

Study Record Dates

First Submitted

January 25, 2018

First Posted

January 31, 2018

Study Start

December 1, 2015

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

August 19, 2020

Results First Posted

August 19, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share