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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Oslo University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00714935
First received: July 10, 2008
Last updated: August 7, 2008
Last verified: August 2008
  Purpose

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


Condition Intervention
Coronary Artery Disease
Decision Making
Behavioral: Decision Counseling Program (DCP)
Behavioral: Coronary Artery Disease Decision Aid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effects of a Decision Aid for Patients With Coronary Artery Disease on Cardiac Risk Factor Modification Behavior and Health Outcomes

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Health Related Quality of Life [ Time Frame: Repeated measures prior to patients angiogram and 2, 4, and 6 months after angiogram ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intermediate outcome: adherence to cardiac risk factor modification behavior [ Time Frame: Repeated measure 2, 4, and 6 months after angiogram ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: April 2008
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3
Decision Counseling Program(DCP) combined with Coronary Artery Disease Decision Aid (CAD-DA) described in Arm 2
Behavioral: Decision Counseling Program (DCP)
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
Behavioral: Coronary Artery Disease Decision Aid

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.

No Intervention: 1
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.

Behavioral: Coronary Artery Disease Decision Aid

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.


Detailed Description:

As above

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00714935

Contacts
Contact: Cornelia M Ruland, PhD +47-2307-5460 cornelia.ruland@rr-research.no
Contact: Liv Wensaas, RN, MNSc +47-9177-4995 liv.wensaas@rr-research.no

Locations
Norway
Rikshospitalet HF University Hospital, Cardiac Outpatient Clinic Recruiting
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
  More Information

No publications provided

Responsible Party: Cornelia M. Ruland, professor, Rikshospitalet HF
ClinicalTrials.gov Identifier: NCT00714935     History of Changes
Other Study ID Numbers: S-07207a
Study First Received: July 10, 2008
Last Updated: August 7, 2008
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Risk Factors
Risk Reduction Behavior
Counseling

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 30, 2014