Planificación de seguridad 6+ (HSI)
5 de agosto de 2026 actualizado por: VA Office of Research and Development
Intervención de prevención del suicidio con medios letales segura y centrada en los veteranos y basada en el servicio de urgencias (CDA 19-076)
El acceso a métodos letales de autolesión, como armas de fuego y medicamentos, aumenta el riesgo de suicidio.
Como tal, las pautas de VA/DoD para la atención de personas con riesgo elevado de suicidio incluyen recomendaciones para que los médicos realicen intervenciones para reducir el acceso a métodos letales de suicidio entre pacientes identificados con riesgo elevado de suicidio.
Sin embargo, no se han desarrollado ni probado intervenciones entre los veteranos que buscan atención de emergencia, una población previamente identificada como de riesgo elevado.
El objetivo de este estudio es realizar una prueba piloto de una intervención de seguridad de medios letales desarrollada específicamente para veteranos que buscan atención en los departamentos de emergencia y entornos de atención de urgencia de la VHA y se identifica que tienen un riesgo elevado de suicidio.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Los investigadores pondrán a prueba la intervención LMS basada en el servicio de urgencias entre hasta 50 veteranos para evaluar la viabilidad y aceptabilidad.
Tipo de estudio
Intervencionista
Inscripción (Actual)
40
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Colorado
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Aurora, Colorado, Estados Unidos, 80045-7211
- Rocky Mountain Regional VA Medical Center, Aurora, CO
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Criterios de inclusión:
Contacto en el servicio de urgencias de VHA o en un entorno de atención de urgencia
->17 años
- Alta a domicilio desde el servicio de urgencias (en lugar de ingreso hospitalario)
- El riesgo de suicidio se determina como intermedio o alto según los resultados del CSRE.
- El paciente elige revisar un Plan de seguridad nuevo o actualizado como parte de su atención clínica.
- Acceso informado por el paciente a armas de fuego y/o medicamentos
Criterio de exclusión:
- No poder dar su consentimiento debido a deterioro cognitivo, gravedad de la enfermedad (incluidos síntomas psiquiátricos), intoxicación por drogas y/o alcohol.
- Acceso telefónico poco confiable
- Aquellos que actualmente se encuentran sin hogar y sin techo.
- Sin dirección postal
- Trastorno por uso activo de opioides o estimulantes
- Trastorno por consumo activo de alcohol con consumo diario de alcohol.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Intervention arm
There is a single intervention arm with no comparator for this pilot study.
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Esta intervención incluye una intervención de seguridad en el hogar impartida por un intervencionista con capacitación específica para facilitar discusiones sobre seguridad de medios letales y la provisión de dispositivos de seguridad sin costo para medicamentos y armas de fuego.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility: Number of Participants Recruited Within One Year
Periodo de tiempo: through study completion, an average of one year
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Ability to recruit 40 Veterans in one year.
Count represents number of participants recruited within one year.
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through study completion, an average of one year
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Feasibility: Number of Participants Who Attend Their 4 Week Follow Up
Periodo de tiempo: approximately 4 weeks
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>80% of participants attend their 4 week follow up.
Count represents number of participants who completed their 4 week follow up visit.
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approximately 4 weeks
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Acceptability: Number of Participants With CSQ Scores ≥24
Periodo de tiempo: day of intervention delivery - day 0; and at 4 weeks
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>80% with score greater than 23 (Client Satisfaction Questionnaire 8).
8 items, each with 4 answer options (1-4) on a Likert Scale.
Likert options are different for each item.
Score range is 8 to 32.
Higher scores indicate higher satisfaction.
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day of intervention delivery - day 0; and at 4 weeks
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Acceptability: Number of Participants Who Reported the Intervention to be Acceptable
Periodo de tiempo: at 4 weeks
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Count of participants who deemed the intervention acceptable via a qualitative evaluation of participant's experiences during the intervention.
Assessed using the Narrative Evaluation of Intervention Interview (NEII): A 16-item semi-structured qualitative interview that helps participants evaluate the process and outcome of interventions.
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at 4 weeks
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Number of Participants Who Found the Intervention Discussion to be Comfortable/Very Comfortable
Periodo de tiempo: day of intervention delivery - day 0; and at 4 weeks
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Count represent the number of participants who reported feeling "Comfortable" or "Very comfortable". "How comfortable did you feel engaging in the discussion?" Likert responses:
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day of intervention delivery - day 0; and at 4 weeks
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Number of Participants Who Found the Intervention to be Very Helpful/Extremely Helpful in Medication Storage Decisions
Periodo de tiempo: day of intervention delivery - day 0; and at 4 weeks
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Count represent the number of participants who reported that their interaction was "Very helpful" or "Extremely helpful". "How helpful was your interaction in making decisions about medication storage and safety?" Likert responses:
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day of intervention delivery - day 0; and at 4 weeks
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Number of Participants Who Found the Intervention to be Very Helpful/Extremely Helpful in Firearm Storage Decisions
Periodo de tiempo: day of intervention delivery - day 0; and at 4 weeks
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Count represent the number of participants who reported that their interaction was "Very helpful" or "Extremely helpful". "How helpful was your interaction in making decisions about firearm storage?" Likert responses:
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day of intervention delivery - day 0; and at 4 weeks
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Number of Participants Who Found the Intervention to be Respectful/Very Respectful of Their Values as Firearm Owners
Periodo de tiempo: day of intervention delivery - day 0; and at 4 weeks
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Count represents the number of participants who reported that their interaction was "Respectful" or "Very respectful". "To what extent was this intervention respectful of your values as a firearm owner? Likert responses:
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day of intervention delivery - day 0; and at 4 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Average Participant Trust in the VA Healthcare System
Periodo de tiempo: Day of intervention delivery (day 0) and at 4 weeks
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"On a scale from 0 to 10, where 10 indicates complete trust and 0 indicates complete distrust (so 5 would indicate that you neither trust, nor distrust), Please indicate your level of trust in the VA healthcare system?" Answer range: 0-10
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Day of intervention delivery (day 0) and at 4 weeks
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Average Participant Beliefs About Importance of Secure Medication Storage When Someone is Suicidal
Periodo de tiempo: Day of intervention delivery (day 0) and at 4 weeks
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"On a scale of 0 to 10, I want to ask you about whether you find the following safety measures to be important.
Someone who answers 0 does not consider them to be important at all, while someone who answers 10 considers them to be extremely important.
It is important to securely store medications when I or someone in my household has had recent thoughts of suicide."
Answer range: 0-10
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Day of intervention delivery (day 0) and at 4 weeks
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Average Participant Beliefs About Importance of Secure Medication Storage Always
Periodo de tiempo: Day of intervention delivery (day 0) and at 4 weeks
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"On a scale of 0 to 10, I want to ask you about whether you find the following safety measures to be important.
Someone who answers 0 does not consider them to be important at all, while someone who answers 10 considers them to be extremely important.
It is always important to securely store medications even if someone is not at risk for suicide in the home."
Answer range: 0-10
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Day of intervention delivery (day 0) and at 4 weeks
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Average Participant Beliefs About Importance of Secure Firearm Storage When Someone is Suicidal
Periodo de tiempo: Day of intervention delivery (day 0) and at 4 weeks
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"On a scale of 0 to 10, I want to ask you about whether you find the following safety measures to be important.
Someone who answers 0 does not consider them to be important at all, while someone who answers 10 considers them to be extremely important.
It is important to securely store firearms when I or someone in my household has had recent thoughts of suicide."
Answer range: 0-10
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Day of intervention delivery (day 0) and at 4 weeks
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Average Participant Beliefs About Importance of Secure Firearm Storage Always
Periodo de tiempo: Day of intervention delivery (day 0) and at 4 weeks
|
"On a scale of 0 to 10, I want to ask you about whether you find the following safety measures to be important.
Someone who answers 0 does not consider them to be important at all, while someone who answers 10 considers them to be extremely important.
It is always important to store firearms securely in a locked space, or with a locking device, even if someone is not at risk for suicide in the home."
Answer range: 0-10
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Day of intervention delivery (day 0) and at 4 weeks
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Average Participant Beliefs About Importance of Unloaded Firearm Storage Always
Periodo de tiempo: Day of intervention delivery (day 0) and at 4 weeks
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"On a scale of 0 to 10, I want to ask you about whether you find the following safety measures to be important.
Someone who answers 0 does not consider them to be important at all, while someone who answers 10 considers them to be extremely important.
It is always important to securely store firearms unloaded even if someone is not at risk for suicide in the home."
Answer range: 0-10
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Day of intervention delivery (day 0) and at 4 weeks
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Average Participant Readiness to Securely Store All Firearms
Periodo de tiempo: Day of intervention delivery - day 0
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"One thing some people consider doing to reduce risk of suicide or injury for themselves and others in their household is to securely store all firearms.
On a scale from 0 to 10, where 0 is not at all, and 10 is completely, how would you rate your readiness to [make a change] like that?" Answer range: 0-10
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Day of intervention delivery - day 0
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Average Participant Readiness to Securely Store All Medications
Periodo de tiempo: Day of intervention delivery at visit #1 (day 0)
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"One thing some people consider doing to reduce risk of suicide or injury for themselves and others in their household is to securely store all medications.
On a scale from 0 to 10, where 0 is not at all, and 10 is completely, how would you rate your readiness to [make a change]?"
Answer range: 0-10
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Day of intervention delivery at visit #1 (day 0)
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Average Number of Firearms in Household
Periodo de tiempo: Day of intervention delivery (day 0) and at 4 weeks
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Number of firearms in household: Answer range: 0 to 10,000
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Day of intervention delivery (day 0) and at 4 weeks
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Number of Participants Who Forget to Take Their Medications Often/Always
Periodo de tiempo: at 4 weeks
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Count represents number of participants who said 'very often' or 'always'. "To what extent have you had difficulty remembering to take your medications in the past month?" Likert responses:
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at 4 weeks
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Number of Participants With Firearms Present in the Home
Periodo de tiempo: Day of intervention delivery (day 0) and at 4 weeks
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Changes in whether household firearms are present in a participant's home from day of intervention delivery (day 0) to 4 weeks.
Count represents the number of participants who reported having at least 1 firearm in their home.
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Day of intervention delivery (day 0) and at 4 weeks
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Number of Participants Securely Storing All Firearms
Periodo de tiempo: Day of intervention delivery (day 0) and at 4 weeks
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Changes in whether household firearms are stored securely. Count represents number of participants who had 'all' firearms locked. "Are any firearms in or around your home currently stored locked?" Answers:
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Day of intervention delivery (day 0) and at 4 weeks
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Number of Participants Securely Storing All Medications
Periodo de tiempo: Day of intervention delivery (day 0) and at 4 weeks
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Changes in whether present medication are all stored securely. Count represents the number of participants who stored 'all' of their medications locked. "Are the medications in your home currently stored locked? (Examples include using a locked cabinet or box)" Answer options:
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Day of intervention delivery (day 0) and at 4 weeks
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Average Importance of Firearm Ownership for Protection
Periodo de tiempo: Day of intervention delivery (day 0) and at 4 weeks
|
"On a scale of 0 to 10, to what extent do you keep your firearms to protect yourself or your loved ones from other people?
Someone who answers 0 does not consider themselves to keep firearms for protection, while someone who answers 10 considers that their firearms are absolutely required for protection."
Answer range: 0-10
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Day of intervention delivery (day 0) and at 4 weeks
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Average Participant Readiness to Store Firearms Outside of the Home With Someone They Trust
Periodo de tiempo: Day of intervention delivery (day 0)
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"One of the safest things someone can do while they're going through a difficult time is to store their firearms outside of the home with someone they trust.
On a scale from 0 to 10, where 0 is not at all, and 10 is completely, how would you rate your readiness to [make a change] like that?" Answer range: 0-10
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Day of intervention delivery (day 0)
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Number of Participants Who Do Not Have Access to Locked Firearm(s)
Periodo de tiempo: Day of intervention delivery (day 0) and at 4 weeks
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Count of people who said they do not have access to the key/combination for their locked firearm. "For the firearms in your home that are locked, who has access to the keys or number combinations that would be needed to access them?" Answer options:
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Day of intervention delivery (day 0) and at 4 weeks
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Number of Participants With Ammunition in the Home
Periodo de tiempo: Day of intervention delivery (day 0) and at 4 weeks
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Changes from day of intervention delivery (day 0) to 4 weeks in whether household ammunition is present.
The presence of ammunition in the home was only asked to participants who stated there were firearms in the home and that they were the owner of at least 1 of the firearms in the home.
Count represents number of participants who reported having ammunition in the home.
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Day of intervention delivery (day 0) and at 4 weeks
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Number of Participants With All Ammunition Locked
Periodo de tiempo: Day of intervention delivery (day 0) and at 4 weeks
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Count of participants who reported having 'all' ammunition in the home securely locked. This measure was only asked to participants who reported that there were firearms in the home, that they were the owner of at least 1 of the firearms in the home, and that there was ammunition in the home. "Is ammunition in or around your home currently stored in a locked place, such as a locked cabinet?" Answer options:
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Day of intervention delivery (day 0) and at 4 weeks
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Number of Participants With Naloxone Prescription in Participant Electronic Health Record
Periodo de tiempo: at 8 weeks
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Count of participants who have a naloxone prescription (yes/no).
Verified through each participant's electronic health record.
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at 8 weeks
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Number of Participants With Verified Return of Medication Safety Envelope
Periodo de tiempo: at 8 weeks
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Verification of returned medication safety envelope (yes/no).
Count represents number of participants who utilized their medication return envelope.
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at 8 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Joseph A Simonetti, MD MPH, Rocky Mountain Regional VA Medical Center, Aurora, CO
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
8 de octubre de 2024
Finalización primaria (Actual)
18 de julio de 2025
Finalización del estudio (Actual)
18 de agosto de 2025
Fechas de registro del estudio
Enviado por primera vez
20 de diciembre de 2023
Primero enviado que cumplió con los criterios de control de calidad
10 de enero de 2024
Publicado por primera vez (Actual)
22 de enero de 2024
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
5 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CDX 24-001
- 1IK2HX002861-01A2 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .