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Rapid Acquisition of Pre- and Post-Incident Disaster Data

Rapid Acquisition of Pre and Post-Incident Disaster Data Study

Background:

- Disasters like earthquakes, floods, and oil spills can give people health problems. Workers who respond to a disaster (like police and firefighters) are directly exposed to contaminants during the emergency response. So they could be at the greatest risk for these problems. Researchers want to gather data about these workers before and right after they go to a disaster. They hope this will help them understand the health effects of disasters.

Objectives:

- To answer questions about the health effects of disaster exposures. To create a participant registry and collect biological samples and health data.

Eligibility:

- People at least 21 years of age who are sent to a disaster area for an emergency response.

Design:

  • Participants will have 1 study visit.
  • Participants will answer questions about:
  • Contact information
  • Health, lifestyle, emotions
  • Medical history
  • Disaster response activities
  • Things they are exposed to in the environment
  • Participants may have blood collected from a vein in the arm.
  • Participants may give biological samples. These may be urine, saliva, cheek cells, nail clippings, or hair.
  • Participants will have a short physical exam. They may have their hip and waist measured over their clothes. The amount of oxygen in their blood may be measured by a sensor on a finger or ear.
  • Participants may have a lung function test. They will take a deep breath and exhale strongly.
  • Participants will be asked to agree to be contacted later to update contact data and learn about future studies.

Descripción general del estudio

Estado

Retirado

Condiciones

Descripción detallada

Disasters are frequently associated with environmental exposures and socioeconomic disruptions that may lead to short- and long-term health consequences. Disaster response workers are potentially at the greatest risk for adverse outcomes due to direct exposure to hazardous environmental contaminants during the emergency response process. The importance of conducting disaster responder research in the immediate aftermath of disasters has become widely recognized, but numerous barriers to doing so have also been recognized. The Rapid Acquisition of Pre- and Post-Incident Disaster Data (RAPIDD) protocol aims to address this gap by registering and characterizing a cohort of disaster response workers early in the disaster response phase to obtain baseline characteristics. Disaster response workers deployed to a disaster area to conduct emergency response activities will be targeted for enrollment. Disaster responders may include police, fire, and emergency medical personnel, as well as other responder groups such as public health personnel and workers involved in environmental remediation and restoration activities. The primary objective of the RAPIDD study is to create a research registry comprised of disaster response workers who are rostered before or immediately after deployment to a disaster area. Important secondary aims are to administer questionnaires and collect biological samples to characterize the cohort in a manner that will allow for future prospective analyses of associations between disaster exposures and health outcomes. In order to achieve these aims, we have developed a protocol, operational manuals, questionnaires, data collection systems, training plans, and other tools to reduce the time required to initiate disaster research. We will also obtain scientific and regulatory approval of the protocol in advance of the disaster in hopes that expedited amendments, with clarifications of the research, will minimize delays associated with various review cycles.

In order to characterize the cohort prior to their involvement with response activities that could lead to disaster-related exposures, we will attempt to collect a wide range of questionnaire data, clinical measurements and biological samples. Questionnaires may cover topics including contact information, demographics, socioeconomic status, medical history, current physical and mental health status, occupational exposures, alcohol and tobacco use and other lifestyle factors.

Biological specimens collected may include the following: blood, urine, nail clippings, saliva, buccal cells or hair. Clinical measurements may include vital signs, anthropometric measurements and spirometry. By seeking IRB and other regulatory approvals for carrying out this research in advance, we anticipate that we will be able to submit expedited amendments to clarify the research plan for a specific disaster so that research can be initiated early in the response phase. However, in the very early phases of some disaster situations, it may not be safe or feasible to collect the data needed to fully characterize a cohort of response workers. In these situations, data collection may be limited to rostering and limited self-collection of biospecimens. As the response effort stabilizes and more becomes known about potential exposures and related adverse health outcomes, we intend to expand our data collection effort, and we will seek expedited regulatory approval to do so.

Tipo de estudio

De observación

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

    • North Carolina
      • Research Triangle Park, North Carolina, Estados Unidos, 20892
        • NIEHS Clinical Research Unit (CRU)

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

21 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Disaster responders deployed to a disaster area to conduct emergency response activities. Disaster responders may include traditional first responders such as police, fire, and emergency medical personnel, as well as non-traditional responder groups such as public health personnel and workers involved in environmental remediation and restoration activities.

Descripción

  • INCLUSION CRITERIA:
  • At least 21 years of age
  • Is part of an eligible disaster responder cohort as defined in Section 5 that has received IRB approval for inclusion

EXCLUSION CRITERIA:

-Any conditions that, in the opinion of the Investigator, would pose an unacceptable risk to the participant or to the validity of the study results

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

Cohortes e Intervenciones

Grupo / Cohorte
Disaster responders
Conducting emergency disaster relief.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Create a research registry comprised of disaster response workers who are rostered before or immediately after deployment to a disaster area.
Periodo de tiempo: On going
This is a registry study conducted to establish and characterize a cohort of disaster responders deployed to a disaster area to conductemergency response activities.
On going

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Gather sociodemographic, health status, occupational exposure, and lifestyle information of the cohort before or immediately after deployment to a disaster area
Periodo de tiempo: Ongoing
Ongoing
Collect, process and store biological samples to allow estimations of disaster-related exposures of the disaster response worker cohort before or immediately after deployment to a disaster area
Periodo de tiempo: Ongoing
Ongoing
Establish a well-characterized disaster response worker cohort that will allow for future analyses of associations between disaster exposures and health outcomes
Periodo de tiempo: Ongoing
Ongoing

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

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)

27 de enero de 2021

Finalización primaria (Actual)

27 de enero de 2021

Finalización del estudio (Actual)

27 de enero de 2021

Fechas de registro del estudio

Enviado por primera vez

13 de junio de 2015

Primero enviado que cumplió con los criterios de control de calidad

13 de junio de 2015

Publicado por primera vez (Estimar)

17 de junio de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de febrero de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

29 de enero de 2021

Última verificación

1 de enero de 2021

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 999915133
  • 15-E-N133

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

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. .

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