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Shared Decision-making: Effects on Cardiac Risk Factor Modification Behavior

3 de noviembre de 2015 actualizado por: Cornelia Ruland, Oslo University Hospital

Effects of a Decision Aid for Patients With Coronary Artery Disease on Cardiac Risk Factor Modification Behavior and Health Outcomes

Decision Aids (DA) to inform patients about health care options and help them to participate in their care choices are widely advocated. The main argument for offering patients a choice is that patients' preferences vary, and health professionals cannot always know what is "best" for an individual, specially when different outcomes have different benefits and risk profiles. The standard modes of treatment for patients with coronary artery disease (CAD) are coronary artery bypass graft (CABG) surgery, medication, and angioplasty. All three treatments for CAD work better when combined with cardiac risk factor modification behavior (CRFMB). CRFMB is important for the general public, but it is even more important for people with CAD because people with CAD have more at stake. In this RCT study we will evaluate the effectiveness of a CAD-DA with and witout an additional decision counseling program (DCP) on health outcomes and quality of life to improve enhancement of adherence to cardiac risk modification behavior. The CAD-DA is developed by the Ottawa Health Research Institute and Division of Clinical Epidemiology at Montreal General Hospital, for CAD patients facing the decision of making lifestyle changes to lower their cardiac risk factors. It provides patients with information about what they can you do to prevent the disease from progressing. The DCP is designed to systematically guide patients through the process of deciding what cardiac risk modification behaviors are important for them to carry out. A RCT where 360 CAD patients > 18 of age scheduled for an angiogram at Rikshospitalet University Hospital in Norway (RH) will be randomly assigned to: (1) CAD-DA group where subjects will receive, for take home, the CAD-DA prior to their scheduled angiogram; (2) DCP group where subjects in addition to the CAD-DA will receive an individual decisional counseling program (DCP) from a trained nurse counselor in their homes prior to their angiogram; and (3) the control group who will receive "usual care". Data will be collected at four points: at the initial visit (T1), 2 months (T2), 4 months (T3) and 6 (T4) months after angiogram

Descripción general del estudio

Descripción detallada

As above

Tipo de estudio

Intervencionista

Inscripción (Actual)

363

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

      • Oslo, Noruega
        • Oslo University Hospital, Rikshospitalet,
      • Oslo, Noruega
        • Rikshospitalet HF University Hospital, Cardiac Outpatient Clinic

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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

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

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: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: 1
Experimental: 3
Decision Counseling Program(DCP) combined with Coronary Artery Disease Decision Aid (CAD-DA) described in Arm 2
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.

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
Health Related Quality of Life
Periodo de tiempo: Repeated measures prior to patients angiogram and 2, 4, and 6 months after angiogram
Repeated measures prior to patients angiogram and 2, 4, and 6 months after angiogram
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
Repeated measures prior to patients angiogram and 2, 4, and 6 months after angiogram

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Intermediate outcome: adherence to cardiac risk factor modification behavior
Periodo de tiempo: Repeated measure 2, 4, and 6 months after angiogram
Repeated measure 2, 4, and 6 months after angiogram
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
Prior to patients angiogram, and 2 months following angiogram

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Cornelia M Ruland, PhD, Oslo University Hospital

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.

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

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

1 de abril de 2008

Finalización primaria (Actual)

1 de agosto de 2009

Finalización del estudio (Actual)

1 de marzo de 2010

Fechas de registro del estudio

Enviado por primera vez

10 de julio de 2008

Primero enviado que cumplió con los criterios de control de calidad

11 de julio de 2008

Publicado por primera vez (Estimar)

14 de julio de 2008

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

4 de noviembre de 2015

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

3 de noviembre de 2015

Última verificación

1 de noviembre de 2015

Más información

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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