search
Back to results

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

Primary Purpose

Coronary Artery Disease, Decision Making

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Decision Counseling Program (DCP)
Coronary Artery Disease Decision Aid
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronary Artery Disease focused on measuring Risk Factors, Risk Reduction Behavior, Counseling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

3

1

2

Arm Description

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

Outcomes

Primary Outcome Measures

Health Related Quality of Life
Health outcomes (angina symptoms, body weight, cholesterol level, blood pressure, health service use)

Secondary Outcome Measures

Intermediate outcome: adherence to cardiac risk factor modification behavior
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

Full Information

First Posted
July 10, 2008
Last Updated
November 3, 2015
Sponsor
Oslo University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00714935
Brief Title
Shared Decision-making: Effects on Cardiac Risk Factor Modification Behavior
Official Title
Effects of a Decision Aid for Patients With Coronary Artery Disease on Cardiac Risk Factor Modification Behavior and Health Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Decision Making
Keywords
Risk Factors, Risk Reduction Behavior, Counseling

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
363 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3
Arm Type
Experimental
Arm Description
Decision Counseling Program(DCP) combined with Coronary Artery Disease Decision Aid (CAD-DA) described in Arm 2
Arm Title
1
Arm Type
No Intervention
Arm Title
2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Decision Counseling Program (DCP)
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Coronary Artery Disease Decision Aid
Intervention Description
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 Outcome Measure Information:
Title
Health Related Quality of Life
Time Frame
Repeated measures prior to patients angiogram and 2, 4, and 6 months after angiogram
Title
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 Outcome Measure Information:
Title
Intermediate outcome: adherence to cardiac risk factor modification behavior
Time Frame
Repeated measure 2, 4, and 6 months after angiogram
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cornelia M Ruland, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital, Rikshospitalet,
City
Oslo
Country
Norway
Facility Name
Rikshospitalet HF University Hospital, Cardiac Outpatient Clinic
City
Oslo
Country
Norway

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
result
Links:
URL
http://urn.nb.no/URN:NBN:no-30927
Description
Wensaas L. Doctoral thesis. University of Oslo

Learn more about this trial

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

We'll reach out to this number within 24 hrs