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Firearm Secure Storage Device Distribution RCT

2 de novembro de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

1858

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Estados Unidos
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • Recrutamento
        • Penn Medicine
        • Contato:
        • Contato:
        • Investigador principal:
          • Mucio (Kit) Delgado, MD, MS
        • Investigador principal:
          • Elinore Kaufman, MD, MSHP, FACS
        • Subinvestigador:
          • Katelin Hoskins, PhD, MBE
        • Subinvestigador:
          • Renee Betancourt, MD
        • Subinvestigador:
          • Michael Harhay, PhD, MPH

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Cable lock distribution (usual practice)

Up to 5 cable locks
Dispositivo: 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.
Comparador Ativo: 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
Dispositivo: 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.

Dispositivo: 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.

Dispositivo: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Proportion of Participants Reporting All Firearms Stored Securely at 30 Days
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Proportion of participants with all firearms stored securely at 3 months
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Number of Participants by Cable Lock Frequency at 30 Days
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Pennsylvania

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

21 de outubro de 2026

Conclusão Primária (Estimado)

1 de outubro de 2029

Conclusão do estudo (Estimado)

1 de setembro de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

1 de outubro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

19 de outubro de 2026

Primeira postagem (Real)

21 de outubro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • 26-6055

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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