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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00763308
A Web-Based Cardiovascular Intervention for the Workplace
Fast Track Program to Create a Web-Based Cardiovascular Intervention for the Workplace
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Heart disease, or cardiovascular disease, refers to a range of diseases including coronary artery disease, heart attack, heart failure, high blood pressure, and stroke. These diseases are all related to problems with the heart and blood vessels, and collectively are the leading cause of death in the United States. Heart attacks or coronary artery disease sometimes have warning signs, but both can occur without warning. Approximately half of all heart attacks are fatal. Forty percent of all deaths in the United States are the result of heart disease.
Certain factors can predict whether people get heart disease. Some of these factors, like biological sex or genes inherited from a person's family, cannot be changed, but many others can. Not smoking, eating well, exercising regularly, and maintaining a healthy weight are some of the things people can do to lower their risk of heart disease. This study will develop and then test an Internet-based program that teaches people about heart health and supports them in changing behaviors that put them at risk for heart disease.
This study will be divided into two phases. In the first phase, researchers will create the Heart Healthy program, show it to focus groups, and try to improve it based on their comments. The goals of the program are to educate users in the fundamentals of heart health and risk factors for heart disease and to provide a system for starting and sustaining lifestyle changes that reduce risk of heart disease. The program will be designed for employee use in a workplace, and a tool kit will be developed for managers to supplement the employee program. The prototype will include modified segments from existing Web-based programs created by a non-profit organization, the ISA Group. The design of the program will be guided by feedback from employees and managers who use it and from experts in cardiology and epidemiology.
In the second phase, the program will be tested in a work site. Employees at risk for heart disease will be recruited and randomly assigned to receive either the Healthy Heart program or treatment as usual. Before and after the intervention, participants will be assessed on knowledge gained, attitudes changed, alterations in health behavior, and reductions in cardiovascular risk. Managers who receive the supplementary program will be tested in knowledge gained and plans for policy or procedural changes. The ultimate goal of this phase is to fully develop the Healthy Heart program for use in industry and health care settings.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Diane K. Deitz, PhD
- Correo electrónico: ddeitz@isagroup.com
Ubicaciones de estudio
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Virginia
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Alexandria, Virginia, Estados Unidos, 22314
- ISA Associates, Inc.
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Contacto:
- Diane Deitz
- Correo electrónico: ddeitz@isagroup.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Works in participating company
- At least one cardiovascular risk factor
Exclusion Criteria:
- No known cardiovascular risks
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 1
Participants will use the Web-based Heart Healthy program.
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The Heart Healthy program will be developed during the course of the study based on goals set by researchers and based on feedback from focus groups.
The goals of the program are to educate users in the fundamentals of heart health and risk factors for heart disease and to provide a system for starting and sustaining lifestyle changes that reduce risk of heart disease.
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Sin intervención: 2
Los participantes recibirán el tratamiento habitual.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Change in health attitudes and behaviors
Periodo de tiempo: Measured pre- and post-intervention
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Measured pre- and post-intervention
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Change in cardiovascular risk status
Periodo de tiempo: Measured pre- and post-intervention
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Measured pre- and post-intervention
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Diane K. Deitz, PhD, ISA Associates
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 535
- R44HL087540-01 (Subvención/contrato del NIH de EE. UU.)
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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