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- Ensayo clínico NCT00714935
Shared Decision-making: Effects on Cardiac Risk Factor Modification Behavior
Effects of a Decision Aid for Patients With Coronary Artery Disease on Cardiac Risk Factor Modification Behavior and Health Outcomes
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Oslo, Noruega
- Oslo University Hospital, Rikshospitalet,
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Oslo, Noruega
- Rikshospitalet HF University Hospital, Cardiac Outpatient Clinic
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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:
- Age 18 and older
- Scheduled for an angiogram
- Able to read, write, and speak Norwegian
- Live within approximately 100 km of Oslo
- Have a telephone
Exclusion Criteria:
- Cognitive impairment
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: 1
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Experimental: 3
Decision Counseling Program(DCP) combined with Coronary Artery Disease Decision Aid (CAD-DA) described in Arm 2
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An individual decisional counseling program (DCP) to help them comprehend the information, adjust this information to their personal illness history and elicit their preferences for cardiac risk fctor modification behavior in light of this personalized information
Coronary Artery Disease Decision Aid (CAD-DA) presented as a booklet called: "Making Choices: Life Changes to Lower Your Risk of Heart Disease and Stroke" The CAD-DA is developed by the Ottawa Health Research Institute and Division of Clinical Epidemiology at Montreal General Hospital, in CAD patients facing the decision of making lifestyle changes to lower their cardiac risk factors and provides patients with information about what they can you do to prevent the disease from progressing. |
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Experimental: 2
Behavioral: Coronary Artery Disease Decision Aid (CAD-DA) presented as a booklet called: "Making Choices: Life Changes to Lower Your Risk of Heart Disease and Stroke" The CAD-DA is developed by the Ottawa Health Research Institute and Division of Clinical Epidemiology at Montreal General Hospital, in CAD patients facing the decision of making lifestyle changes to lower their cardiac risk factors and provides patients with information about what they can you do to prevent the disease from progressing. |
Coronary Artery Disease Decision Aid (CAD-DA) presented as a booklet called: "Making Choices: Life Changes to Lower Your Risk of Heart Disease and Stroke" The CAD-DA is developed by the Ottawa Health Research Institute and Division of Clinical Epidemiology at Montreal General Hospital, in CAD patients facing the decision of making lifestyle changes to lower their cardiac risk factors and provides patients with information about what they can you do to prevent the disease from progressing. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Health Related Quality of Life
Periodo de tiempo: Repeated measures prior to patients angiogram and 2, 4, and 6 months after angiogram
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Repeated measures prior to patients angiogram and 2, 4, and 6 months after angiogram
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Health outcomes (angina symptoms, body weight, cholesterol level, blood pressure, health service use)
Periodo de tiempo: Repeated measures prior to patients angiogram and 2, 4, and 6 months after angiogram
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Repeated measures prior to patients angiogram and 2, 4, and 6 months after angiogram
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Intermediate outcome: adherence to cardiac risk factor modification behavior
Periodo de tiempo: Repeated measure 2, 4, and 6 months after angiogram
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Repeated measure 2, 4, and 6 months after angiogram
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Mediating variables: knowledge, decisional conflict, intention to adhere to cardiac risk factor modification behavior, perceived susceptibility and severity of CAD progression, and benefits and barriers of cardiac risk factor modification behavior
Periodo de tiempo: Prior to patients angiogram, and 2 months following angiogram
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Prior to patients angiogram, and 2 months following angiogram
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Cornelia M Ruland, PhD, Oslo University Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- Wensaas L. Effects of a decision aid with and without additional decisional counseling for patients being examined for coronary artery disease on cardiac risk reduction behavior and health outcomes : A randomized controlled trial. Doctoral thesis. University of Oslo, 2012
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- S-07207a
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