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Firearm Secure Storage Device Distribution RCT

2 listopada 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

1858

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Stany Zjednoczone
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
        • Rekrutacyjny
        • Penn Medicine
        • Kontakt:
        • Kontakt:
        • Główny śledczy:
          • Mucio (Kit) Delgado, MD, MS
        • Główny śledczy:
          • Elinore Kaufman, MD, MSHP, FACS
        • Pod-śledczy:
          • Katelin Hoskins, PhD, MBE
        • Pod-śledczy:
          • Renee Betancourt, MD
        • Pod-śledczy:
          • Michael Harhay, PhD, MPH

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Cable lock distribution (usual practice)

Up to 5 cable locks
Urządzenie: 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.
Aktywny 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
Urządzenie: 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.

Urządzenie: 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.

Urządzenie: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Proportion of Participants Reporting All Firearms Stored Securely at 30 Days
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Proportion of participants with all firearms stored securely at 3 months
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants by Cable Lock Frequency at 30 Days
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Pennsylvania

Śledczy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

21 października 2026

Zakończenie podstawowe (Szacowany)

1 października 2029

Ukończenie studiów (Szacowany)

1 września 2030

Daty rejestracji na studia

Pierwszy przesłany

1 października 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

19 października 2026

Pierwszy wysłany (Rzeczywisty)

21 października 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

5 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • 26-6055

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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