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Completed

NCT Number: NCT00714935

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital, Rikshospitalet,, Oslo, Norway

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About this study

As above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Decision Counseling Program (DCP)

Behavioral

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

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.

Primary outcomes

  1. Health Related Quality of Life

    Time frame: Repeated measures prior to patients angiogram and 2, 4, and 6 months after angiogram

  2. Health outcomes (angina symptoms, body weight, cholesterol level, blood pressure, health service use)

    Time frame: Repeated measures prior to patients angiogram and 2, 4, and 6 months after angiogram

Secondary outcomes

  1. Intermediate outcome: adherence to cardiac risk factor modification behavior

    Time frame: Repeated measure 2, 4, and 6 months after angiogram

  2. 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

    Time frame: Prior to patients angiogram, and 2 months following angiogram

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Jul 14, 2008
Registry last updated
Nov 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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