InjuriesNCT03417752

The Use of Public Messaging for the Promotion of Firearm Safety to Veterans

A study testing Exposure to firearm safety PSA and Exposure to health promotion PSA in people with Injuries, run by Canandaigua VA Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 89 yearsHealthy volunteers can take part
Conditions the study is for: Injuries
What is being tested?: Exposure to firearm safety PSA and Exposure to health promotion PSA
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 474 participants
Where: No sites listed yet
Study dates: Dec 2015to Mar 2020
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 89 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: Unlocking the Potential of VA Means Safety Programs: An Examination of the Use of Public Messaging for the Promotion of Firearm Safety to Veterans

Conditions: Injuries
Being tested: Exposure to firearm safety PSA, Exposure to health promotion PSA
Medical subject headings: Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Exposure to firearm safety PSAOther
Exposed to firearm safety PSA
Exposure to health promotion PSAOther
Exposed to general health promotion PSA

Study groups in NCT03417752
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Exposure to firearm safety PSA; Other: Exposure to health promotion PSA
Active control	Active comparator	Exposure to the general health promotion video once per week for 3 weeks. Receives: Other: Exposure to health promotion PSA

What is being measured

The primary outcome is the main question the study is designed to answer.

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."
Measured: 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."
Measured: 3 weeks post-baseline

Secondary outcomes (2)

Number of Participants Who Self-reported Firearm Storage Behavior at Baseline
Number of participants at baseline with self-reported safe household firearm storage (restricted to participants with self-reported firearm access)
Measured: baseline
Number of Participants Who Self-reported Firearm Storage Behavior at Exit
Number of participants at exit with self-reported safe household firearm storage (restricted to participants with self-reported firearm access)
Measured: 3 weeks post-baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2015Mar 2020

First posted31 Jan 2018
Study startDec 2015
Primary completionMar 2020
Study completionMar 2020

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.
Other trials for InjuriesStudies of the same condition, open and under way.
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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 474 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03417752
Sponsor's protocol ID: 910434
Status last verified: Aug 2020
First submitted: 25 Jan 2018
Last updated: 19 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Unlocking the Potential of VA Means Safety Programs: An Examination of the Use of Public Messaging for the Promotion of Firearm Safety to Veterans
ClinicalTrials.gov ID: NCT03417752
Acronym / sponsor ID: 910434
Conditions: Injuries
Study type: Interventional
Recruitment status: Completed
Enrolment: 474 participants (actual)
Lead sponsor: Canandaigua VA Medical CenterUS federal agency
Study start: Dec 2015 (actual)
Primary completion: Mar 2020 (actual)
Study completion: Mar 2020 (actual)
First posted: 31 Jan 2018 (actual)
Results: Posted 19 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Exposure to firearm safety Public Service Announcement (PSA)	Experimental	Other: Exposure to firearm safety PSAExposure to the firearm safety PSA (approx. 2.5 minutes long) once per week for 3 weeks.
Exposure to a mix of PSAs	Experimental	Other: Exposure to firearm safety PSA, Other: Exposure to health promotion PSAExposure 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.
Active control	Active comparator	Other: Exposure to health promotion PSAExposure to the general health promotion video once per week for 3 weeks.

Who may qualify

Ages: 18 to 89 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (4 listed)

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

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
Exposure to firearm safety PSAExposed to firearm safety PSA	Other	Exposure to a mix of PSAs, Exposure to firearm safety Public Service Announcement (PSA)
Exposure to health promotion PSAExposed to general health promotion PSA	Other	Active control, Exposure to a mix of PSAs

Primary outcome

Number of Participants With Self-reported Injury Prevention Belief
Time frame: baseline
Number of participants with self-reported response to belief that "safe storage of household firearms is effective for reducing injury or death."
Number of Participants With Self-reported Injury Prevention Belief
Time frame: 3 weeks post-baseline
Number of participants with self-reported response to belief that "safe storage of household firearms is effective for reducing injury or death."

2 secondary outcomes

Number of Participants Who Self-reported Firearm Storage Behavior at Baseline
Time frame: baseline
Number of Participants Who Self-reported Firearm Storage Behavior at Exit
Time frame: 3 weeks post-baseline

Results and safety

Results posted to the registry on 19 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exposure to Firearm Safety PSA	149	115
Exposure to a Mix of PSAs	175	133
Active Control	150	110

Primary outcome: Number of Participants With Self-reported Injury Prevention Belief

Time frame: baseline. Count of participants. Unit: Participants

Measure	Exposure to Firearm Safety PSA n = 115	Exposure to a Mix of PSAs n = 133	Active Control n = 110
Agree	66	73	57
Disagree	49	60	53

Population analysed: Analyses were restricted to participants that completed both baseline and exit surveys. Descriptive statistics were tabulated by frequencies and weighted percentages or mean and standard deviation, as appropriate.

Primary outcome: Number of Participants With Self-reported Injury Prevention Belief

Time frame: 3 weeks post-baseline. Count of participants. Unit: Participants

Measure	Exposure to Firearm Safety PSA n = 115	Exposure to a Mix of PSAs n = 133	Active Control n = 110
Agree	71	79	64
Disagree	44	54	46

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: over 1 calendar year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exposure to Firearm Safety PSA	0 of 115 (0%)	0 of 115 (0%)	0 of 115
Exposure to a Mix of PSAs	0 of 133 (0%)	0 of 133 (0%)	0 of 133
Active Control	0 of 110 (0%)	0 of 110 (0%)	0 of 110

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Elizabeth Karras, PhD principal investigator

VA Center of Excellence for Suicide Prevention

Questions about this trial

What is this clinical trial studying?

A study testing Exposure to firearm safety PSA and Exposure to health promotion PSA in people with Injuries, run by Canandaigua VA Medical Center.

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 5 inclusion and 4 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 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

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 19 Aug 2020). 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?

Number of Participants With Self-reported Injury Prevention Belief (time frame: baseline). The study lists 2 primary outcomes in all. 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 NCT03417752.

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 19 Aug 2020.