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Firearm Secure Storage Device Distribution RCT

2. november 2026 oppdatert av: University of Pennsylvania

Comparative Effectiveness of Firearm Secure Storage Device Distribution Strategies: A Hybrid Type 1 Effectiveness-Implementation Randomized Clinical Trial

This study aims to learn how to best promote safe firearm storage in the community. Firearm injuries are a major public health concern, and securely storing firearms can help prevent accidental injuries, suicide, and unauthorized access. This research will test whether providing people with a choice of firearm storage devices improves safe storage practices compared to providing standard cable locks alone. Adults who are patients, visitors, or employees at participating Penn Medicine community health centers may choose to enroll by scanning a QR code displayed at the site. After reviewing study information and providing consent, participants will complete a short online survey about firearm ownership and storage practices. Participants will then be randomly assigned to receive either cable locks or a choice of storage devices such as a lock box and/or cable locks, which will be mailed to their home at no cost. Participants will receive firearm safety educational materials and will be asked to complete brief follow-up surveys by text message about one month and three months later. Some participants and health center staff may also be invited to participate in interviews about their experiences with the program. The goal of this research is to identify practical and acceptable ways for health systems to support safe firearm storage and reduce firearm-related injuries in diverse communities.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

1858

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Rekruttering
        • Penn Medicine
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Mucio (Kit) Delgado, MD, MS
        • Hovedetterforsker:
          • Elinore Kaufman, MD, MSHP, FACS
        • Underetterforsker:
          • Katelin Hoskins, PhD, MBE
        • Underetterforsker:
          • Renee Betancourt, MD
        • Underetterforsker:
          • Michael Harhay, PhD, MPH

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patient, visitor, or employee at enrollment site
  • Can access QR code survey at enrollment site via smartphone and have access to text messaging
  • Have a residential [U.S.] mailing address
  • Report a firearm at home
  • Request a secure storage device

Exclusion Criteria:

  • Prior enrollment from same household address (needed to preserve independence of study observations)
  • Inability to complete study consent and assessments in English or Spanish

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Cable lock distribution (usual practice)

Up to 5 cable locks
Enhet: Cable locks

Participants assigned to this intervention will receive up to five firearm cable locks at no cost. The cable locks will be mailed to the participant's home along with firearm safety educational materials.
Aktiv komparator: Choice of a lock box and/or cable locks (choice of preferred devices)

Preferred device option, with choices of: (A) up to 5 cable locks; (B) lock box only; or (C) lock box plus up to 4 cable locks
Enhet: Cable locks

Participants assigned to this intervention will receive up to five firearm cable locks at no cost. The cable locks will be mailed to the participant's home along with firearm safety educational materials.

Enhet: Lock box

Participants assigned to this intervention will receive one firearm lock box at no cost. The lock box will be mailed to the participant's home along with firearm safety educational materials.

Enhet: Lock box and cable locks

Participants assigned to this intervention will receive one firearm lock box and up to four firearm cable locks at no cost. The storage devices will be mailed to the participant's home along with firearm safety educational materials.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of Participants Reporting All Firearms Stored Securely at 30 Days
Tidsramme: 30 days after enrollment

Proportion of participants reporting that all firearms in or around their home are stored securely (vs. some or none) on the 30-day follow-up survey. Secure storage will be assessed through participant self-report using the following response options: Yes, all of them (1); Yes, some of them (2); None of them (3); Not sure (4); No guns in or around home (5); and Prefer not to answer (6).
30 days after enrollment

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of participants with all firearms stored securely at 3 months
Tidsramme: 3 months after enrollment

Proportion of participants reporting that all firearms in the household are stored securely (vs. some or none) on the 3-month follow-up survey.
3 months after enrollment
Proportion of participants changing from no firearms stored securely to some or all firearms stored securely at 1 month
Tidsramme: 30 days after enrollment

Participants reporting that some household firearms are stored securely (vs. none) on 1 month follow-up survey after device distribution.
30 days after enrollment
Proportion of participants changing from no firearms stored securely to some or all firearms stored securely at 3 months
Tidsramme: 3 months after enrollment

Participants reporting that some household firearms are stored securely (vs. none) on 3 month follow-up survey after device distribution.
3 months after enrollment
Number of preferred firearm storage devices requested
Tidsramme: Baseline (enrollment)

Among patients randomized to the preferred device arm, the number of firearm storage devices requested by participants will be assessed.
Baseline (enrollment)
Incremental intervention cost per participant
Tidsramme: Baseline (enrollment)

Incremental cost of delivering the intervention, including the cost of firearm storage devices and associated shipping costs. Costs will be calculated in US dollar per participant
Baseline (enrollment)

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants by Cable Lock Frequency at 30 Days
Tidsramme: 30 days after enrollment

Frequency of cable lock use among participants reporting use of cable locks on firearms at the 30-day follow-up assessment. Participants will report how often cable locks are used using the following response options:

  • Always (1)
  • More than half the time (2)
  • Less than half the time (3)
30 days after enrollment
Number of Participants by Cable Lock Frequency at 90 Days
Tidsramme: 90 days after enrollment

Frequency of cable lock use among participants reporting use of cable locks on firearms at the 90-day follow-up assessment. Participants will report how often cable locks are used using the following response options:

  • Always (1)
  • More than half the time (2)
  • Less than half the time (3)
90 days after enrollment
Number of Participants by Cable Lock Frequency at 180 Days
Tidsramme: 180 days after enrollment

Frequency of cable lock use among participants reporting use of cable locks on firearms at the 180-day follow-up assessment. Participants will report how often cable locks are used using the following response options:

  • Always (1)
  • More than half the time (2)
  • Less than half the time (3)
180 days after enrollment
Number of Cable Locks by Recipient Type at 30 Days
Tidsramme: 30 days after enrollment

Number of cable locks reported as being held by the participant (self), family members, friends, or other individuals at the 30-day follow-up assessment. Participants will report the number of cable locks held by each recipient type.
30 days after enrollment
Number of Cable Locks by Recipient Type at 90 Days
Tidsramme: 90 days after enrollment

Number of cable locks reported as being held by the participant (self), family members, friends, or other individuals at the 90-day follow-up assessment. Participants will report the number of cable locks held by each recipient type.
90 days after enrollment
Number of Cable Locks by Recipient Type at 180 Days
Tidsramme: 180 days after enrollment

Number of cable locks reported as being held by the participant (self), family members, friends, or other individuals at the 180-day follow-up assessment. Participants will report the number of cable locks held by each recipient type.
180 days after enrollment
Number of Participants by Lock Box Usage Category at 30 Days
Tidsramme: 30 days after enrollment

Lock box usage will be assessed through participant self-report at the 30-day follow-up. Participants will report whether the lock box is being used to secure a previously unlocked firearm, replace an existing firearm lock, or is not being used for a firearm. The number of participants selecting each response category will be reported.
30 days after enrollment
Number of Participants by Lock Box Usage Category at 90 Days
Tidsramme: 90 days after enrollment

Lock box usage will be assessed through participant self-report at the 90-day follow-up. Participants will report whether the lock box is being used to secure a previously unlocked firearm, replace an existing firearm lock, or is not being used for a firearm. The number of participants selecting each response category will be reported.
90 days after enrollment
Number of Participants by Lock Box Usage Category at 180 Days
Tidsramme: 180 days after enrollment

Lock box usage will be assessed through participant self-report at the 180-day follow-up. Participants will report whether the lock box is being used to secure a previously unlocked firearm, replace an existing firearm lock, or is not being used for a firearm. The number of participants selecting each response category will be reported.
180 days after enrollment
Number of Participants by Lock Box Recipient Type at 30 Days
Tidsramme: 30 days after enrollment

Lock box possession will be assessed through participant self-report at the 30-day follow-up. Participants will identify who has the lock box using the following response categories: self, family member, friend, or other individual. The number of participants selecting each response category will be reported.
30 days after enrollment
Number of Participants by Lock Box Recipient Type at 90 Days
Tidsramme: 90 days after enrollment

Lock box possession will be assessed through participant self-report at the 90-day follow-up. Participants will identify who has the lock box using the following response categories: self, family member, friend, or other individual. The number of participants selecting each response category will be reported.
90 days after enrollment
Number of Participants by Lock Box Recipient Type at 180 Days
Tidsramme: 180 days after enrollment

Lock box possession will be assessed through participant self-report at the 180-day follow-up. Participants will identify who has the lock box using the following response categories: self, family member, friend, or other individual. The number of participants selecting each response category will be reported.
180 days after enrollment
Number of Participants by Lock Box Frequency at 30 Days
Tidsramme: 30 days after enrollment

Frequency of lock box use will be assessed through participant self-report at the 30-day follow-up. Participants will report how often the lock box is used using the following response categories: Always (1), More than half the time (2), and Less than half the time (3). The number of participants selecting each response category will be reported.
30 days after enrollment
Number of Participants by Lock Box Frequency at 90 Days
Tidsramme: 90 days after enrollment

Frequency of lock box use will be assessed through participant self-report at the 90-day follow-up. Participants will report how often the lock box is used using the following response categories: Always (1), More than half the time (2), and Less than half the time (3). The number of participants selecting each response category will be reported.
90 days after enrollment
Number of Participants by Lock Box Frequency at 180 Days
Tidsramme: 180 days after enrollment

Frequency of lock box use will be assessed through participant self-report at the 180-day follow-up. Participants will report how often the lock box is used using the following response categories: Always (1), More than half the time (2), and Less than half the time (3). The number of participants selecting each response category will be reported.
180 days after enrollment
Number of Participants by Cable Lock Usage Category at 30 Days
Tidsramme: 30 days after enrollment

Cable lock usage will be assessed through participant self-report at the 30-day follow-up. Participants will report whether the cable lock is being used to secure a previously unlocked firearm, replace an existing firearm lock, or is not being used for a firearm. The number of participants selecting each response category will be reported.
30 days after enrollment
Number of Participants by Cable Lock Usage Category at 90 Days
Tidsramme: 90 days after enrollment

Cable lock usage will be assessed through participant self-report at the 90-day follow-up. Participants will report whether the cable lock is being used to secure a previously unlocked firearm, replace an existing firearm lock, or is not being used for a firearm. The number of participants selecting each response category will be reported.
90 days after enrollment
Number of Participants by Cable Lock Usage Category at 180 Days
Tidsramme: 180 days after enrollment

Cable lock usage will be assessed through participant self-report at the 180-day follow-up. Participants will report whether the cable lock is being used to secure a previously unlocked firearm, replace an existing firearm lock, or is not being used for a firearm. The number of participants selecting each response category will be reported.
180 days after enrollment
Number of Participants Who Reported Using Injury Prevention Resources at 30 days
Tidsramme: 30 days after enrollment

Assessed via a 3-item self-reported follow-up questionnaire evaluating participant engagement with provided injury prevention resources. The questionnaire assesses whether participants accessed the texted gun safety webpage, whether they spoke with the Injury Prevention Coordinator (including reasons for contact), and whether they have unmet gun safety resource needs.
30 days after enrollment
Number of Participants Who Reported Using Injury Prevention Resources at 90 days
Tidsramme: 90 days after enrollment

Assessed via a 3-item self-reported follow-up questionnaire evaluating participant engagement with provided injury prevention resources. The questionnaire assesses whether participants accessed the texted gun safety webpage, whether they spoke with the Injury Prevention Coordinator (including reasons for contact), and whether they have unmet gun safety resource needs.
90 days after enrollment
Number of Participants Who Reported Using Injury Prevention Resources at 180 days
Tidsramme: 180 days after enrollment

Assessed via a 3-item self-reported follow-up questionnaire evaluating participant engagement with provided injury prevention resources. The questionnaire assesses whether participants accessed the texted gun safety webpage, whether they spoke with the Injury Prevention Coordinator (including reasons for contact), and whether they have unmet gun safety resource needs.
180 days after enrollment

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Pennsylvania

Etterforskere

  • Hovedetterforsker: Mucio (Kit) Delgado, MD, MS, University of Pennsylvania
  • Hovedetterforsker: Elinore Kaufman, MD, MSHP, University of Pennsylvania

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

21. oktober 2026

Primær fullføring (Antatt)

1. oktober 2029

Studiet fullført (Antatt)

1. september 2030

Datoer for studieregistrering

Først innsendt

1. oktober 2026

Først innsendt som oppfylte QC-kriteriene

19. oktober 2026

Først lagt ut (Faktiske)

21. oktober 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 26-6055

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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