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Firearm Secure Storage Device Distribution RCT

2 ноября 2026 г. обновлено: 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.

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Оцененный)

1858

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Учебное резервное копирование контактов

Места учебы

  • Соединенные Штаты
    • Pennsylvania
      • Philadelphia, Pennsylvania, Соединенные Штаты, 19104
        • Рекрутинг
        • Penn Medicine
        • Контакт:
        • Контакт:
        • Главный следователь:
          • Mucio (Kit) Delgado, MD, MS
        • Главный следователь:
          • Elinore Kaufman, MD, MSHP, FACS
        • Младший исследователь:
          • Katelin Hoskins, PhD, MBE
        • Младший исследователь:
          • Renee Betancourt, MD
        • Младший исследователь:
          • Michael Harhay, PhD, MPH

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Все

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Профилактика
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Активный компаратор: Cable lock distribution (usual practice)

Up to 5 cable locks
Устройство: 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.
Активный компаратор: 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
Устройство: 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.

Устройство: 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.

Устройство: 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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Proportion of Participants Reporting All Firearms Stored Securely at 30 Days
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Proportion of participants with all firearms stored securely at 3 months
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Number of Participants by Cable Lock Frequency at 30 Days
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

University of Pennsylvania

Следователи

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

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

21 октября 2026 г.

Первичное завершение (Оцененный)

1 октября 2029 г.

Завершение исследования (Оцененный)

1 сентября 2030 г.

Даты регистрации исследования

Первый отправленный

1 октября 2026 г.

Впервые представлено, что соответствует критериям контроля качества

19 октября 2026 г.

Первый опубликованный (Действительный)

21 октября 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

5 ноября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

2 ноября 2026 г.

Последняя проверка

1 ноября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Другие идентификационные номера исследования

  • 26-6055

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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