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Clinical Trials/NCT00714935
NCT00714935
Completed
Not Applicable

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

Oslo University Hospital2 sites in 1 country363 target enrollmentApril 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Oslo University Hospital
Enrollment
363
Locations
2
Primary Endpoint
Health Related Quality of Life
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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

Detailed Description

As above

Registry
clinicaltrials.gov
Start Date
April 2008
End Date
March 2010
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Cornelia Ruland

Professor

Oslo University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Health Related Quality of Life

Time Frame: 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)

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

Secondary Outcomes

  • Intermediate outcome: adherence to cardiac risk factor modification behavior(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(Prior to patients angiogram, and 2 months following angiogram)

Study Sites (2)

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