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

NCT00714935 | Completed

• 1 other identifier: S-07207a
• Study Type: interventional
• Target: 363
• Locations: 1 country
• Sites: 2

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

Conditions

Coronary Artery Disease; Decision Making

Keywords

Risk Factors; Risk Reduction Behavior; Counseling

Outcome Measures

Primary Outcomes (2)

• Health Related Quality of Life

  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)

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

Secondary Outcomes (2)

• 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 Arms (3)

3

EXPERIMENTAL

Decision Counseling Program(DCP) combined with Coronary Artery Disease Decision Aid (CAD-DA) described in Arm 2

Behavioral: Decision Counseling Program (DCP); Behavioral: Coronary Artery Disease Decision Aid

1

NO INTERVENTION

2

EXPERIMENTAL

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.

Behavioral: Coronary Artery Disease Decision Aid

Interventions

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

3

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.

2; 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Cognitive impairment

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (2)

Oslo University Hospital, Rikshospitalet,

Oslo, Norway

Location

Rikshospitalet HF University Hospital, Cardiac Outpatient Clinic

Oslo, Norway

Location

Related Publications (1)

• 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

  RESULT

MeSH Terms

Conditions

Coronary Artery Disease; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Behavior

Study Officials

• Cornelia M Ruland, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 10, 2008
• First Posted: July 14, 2008
• Study Start: April 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: March 1, 2010
• Last Updated: November 4, 2015

Record last verified: 2015-11

Locations

NO (2)