Secondary Manifestations of Arterial Disease - Influence of Cardiovascular Prognosis and Treatment Effect Predictions on Patient and Physician Decision-Making: a Three-armed, Blinded, Randomized Controlled Trial
Completed
- Conditions
- Clinically manifest atherosclerotic diseaseAtherosclerosisCardiovascular disease
- Registration Number
- NL-OMON45689
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 303
Inclusion Criteria
1. Inclusion in the SMART study (NL45885.041.13)
2. Clinically manifest cardiovascular disease, such as a confirmed diagnosis or strong clinical suspicion of one of the following: coronary artery disease, cerebrovascular disease, peripheral artery disease.
3. Use of statin medication at baseline
4. 45-80 years of age
5. Rankin Scale <3
Exclusion Criteria
1. Pregnancy
2. Terminal malignancy or short life-expectancy
3. No follow-up possible
4. Inability to effectively communicate in Dutch
5. No informed consent (IC) signed
6. Baseline questionnaire not returned
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Patient experience with decision-making, measured using the Decisional Conflict<br /><br>Scale (DCS), 1 month post-intervention. </p><br>
- Secondary Outcome Measures
Name Time Method