Actively Recruiting
Effectiveness of Decision Support for Cardiovascular Risk Management in People With Cardiovascular Disease
Led by dr.Frank L.J. Visseren · Updated on 2025-03-12
1200
Participants Needed
8
Research Sites
201 weeks
Total Duration
On this page
Sponsors
D
dr.Frank L.J. Visseren
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study aims to improve the way patients with cardiovascular diseases are informed about their treatment options. It explores methods to support shared decision-making between patients and doctors. In some cases, doctors will take extra time to discuss treatment options in detail. To assess the impact, some patients will be asked to complete questionnaires after their clinic visits.
CONDITIONS
Official Title
Effectiveness of Decision Support for Cardiovascular Risk Management in People With Cardiovascular Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Established ASCVD with at least 30 days since last cardiovascular event or diagnosis
- Documented ASCVD according to 2021 European Society of Cardiology guidelines, confirmed clinically or by imaging
- Age between 40 and 80 years
- Attending Cardiology or Vascular Medicine outpatient clinics
- Sufficient understanding of the Dutch language
- Written informed consent provided
You will not qualify if you...
- Participating in other interventional medication studies or studies affecting therapy plan
- Life expectancy less than 2 years as assessed by a healthcare professional
- Inability to obtain individual risk predictions with SMART2 model due to:
- Systolic Blood Pressure less than 90 mmHg or greater than 200 mmHg
- Total cholesterol less than 2.5 mmol/L or greater than 8 mmol/L
- HDL cholesterol less than 0.6 mmol/L or greater than 2.5 mmol/L
- LDL cholesterol less than 0.1 mmol/L or greater than 7.4 mmol/L
- Estimated Glomerular Filtration Rate less than 30 ml/min/1.73m2 or dialysis
- Active treatment for malignancy, pregnancy, history of organ transplantation, or liver failure
- Previous participation in the 2-DECIDE study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands, 1815 JD
Not Yet Recruiting
2
Meander Medisch Centrum
Amersfoort, Netherlands, 3813 TZ
Not Yet Recruiting
3
Deventer Ziekenhuis
Deventer, Netherlands, 7416 SE
Actively Recruiting
4
Ziekenhuis Gelderse Vallei
Ede, Netherlands, 6716 RP
Not Yet Recruiting
5
Radboudumc
Nijmegen, Netherlands, 6525 GA
Not Yet Recruiting
6
HagaZiekenhuis
The Hague, Netherlands, 2545 AA
Not Yet Recruiting
7
Diakonessenhuis
Utrecht, Netherlands, 3582 KE
Actively Recruiting
8
UMC Utrecht
Utrecht, Netherlands, 3584 CX
Not Yet Recruiting
Research Team
E
Elbrich Wempe, MD, PhD candidate
CONTACT
S
Steven Hageman, Assistant professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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