Coronary Artery DiseaseNCT00714935
Shared Decision-making: Effects on Cardiac Risk Factor Modification Behavior
A study testing Decision Counseling Program (DCP) and Coronary Artery Disease Decision Aid in people with Coronary Artery Disease and Decision Making, run by Oslo University Hospital at 2 sites in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Decision Making
- What is being tested?
- Decision Counseling Program (DCP) and Coronary Artery Disease Decision Aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 363 participants
- Where
- 2 sitesNorway
- Study dates
- Apr 2008to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cognitive impairment
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Oslo University Hospital, Rikshospitalet,
Oslo
Rikshospitalet HF University Hospital, Cardiac Outpatient Clinic
Oslo
About this study
Official title: Effects of a Decision Aid for Patients With Coronary Artery Disease on Cardiac Risk Factor Modification Behavior and Health Outcomes
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
Read the detailed description
As above
- Conditions
- Coronary Artery Disease, Decision Making
- Being tested
- Decision Counseling Program (DCP), Coronary Artery Disease Decision Aid
- Keywords
- Risk Factors, Risk Reduction Behavior, Counseling
- Medical subject headings
- Coronary Artery Disease, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision Counseling Program (DCP)Behavioural
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 AidBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 3 | Experimental | Decision Counseling Program(DCP) combined with Coronary Artery Disease Decision Aid (CAD-DA) described in Arm 2 Receives: Behavioral: Decision Counseling Program (DCP); Behavioral: Coronary Artery Disease Decision Aid |
| 1 | No intervention | Not described |
| 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. Receives: Behavioral: Coronary Artery Disease Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Related Quality of Life
Measured: 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)
Measured: 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
Measured: 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
Measured: Prior to patients angiogram, and 2 months following angiogram
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startApr 2008
- Primary completionAug 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cornelia Ruland, Oslo University Hospital
- Investigators
- Cornelia M Ruland, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714935
- Sponsor's protocol ID
- S-07207a
- Status last verified
- Nov 2015
- First submitted
- 10 Jul 2008
- Last updated
- 4 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Decision Aid for Patients With Coronary Artery Disease on Cardiac Risk Factor Modification Behavior and Health Outcomes
- ClinicalTrials.gov ID
- NCT00714935
- Acronym / sponsor ID
- S-07207a
- Conditions
- Coronary Artery Disease, Decision Making
- Keywords
- Risk Factors, Risk Reduction Behavior, Counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 14 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3 | Experimental | Behavioral: Decision Counseling Program (DCP), Behavioral: Coronary Artery Disease Decision AidDecision Counseling Program(DCP) combined with Coronary Artery Disease Decision Aid (CAD-DA) described in Arm 2 |
| 1 | No intervention | – |
| 2 | Experimental | Behavioral: Coronary Artery Disease Decision AidBehavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | 3 |
| Coronary Artery Disease Decision AidCoronary 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. | Behavioural | 2, 3 |
Primary outcome
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
2 secondary outcomes
Intermediate outcome: adherence to cardiac risk factor modification behavior
Time frame: 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
Time frame: Prior to patients angiogram, and 2 months following angiogram
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2015.
- Results publicationWensaas 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
- Wensaas L. Doctoral thesis. University of OsloLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cornelia M Ruland, PhD principal investigator
Oslo University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Counseling Program (DCP) and Coronary Artery Disease Decision Aid in people with Coronary Artery Disease and Decision Making, run by Oslo University Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Related Quality of Life (time frame: Repeated measures prior to patients angiogram and 2, 4, and 6 months after angiogram). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00714935, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2015.