An interventional study of PROSPERA-program in Cardiovascular Diseases, sponsored by Leiden University Medical Center. Enrolling by invitation at 1 site in Netherlands. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Leiden University Medical Center · Not applicable, Interventional, and Prevention
The PROSPERA-program is a complex multilevel approach that includes training for healthcare providers, a risk assessment process, and decision support tools to help match patients with the appropriate treatment based on their care needs.
The goal of this clinical trial is to determine if the PROSPERA-program can improve the cardiovascular risk profile in patients aged 40-90 years enrolled in primary care programs for increased cardiovascular risk, such as cardiovascular disease, increased vascular risk, or diabetes.
The main question it aims to answer is:
Researchers will compare the PROSPERA-program with standard cardiovascular care to see if the program enhances cardiovascular population health in primary care.
Additionally, the study will assess how well the PROSPERA-program fits into the workflow of primary care providers and supports shared decision-making.
Participants will:
5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.
This study's planned enrollment of 848 is above the median of 100 across 3,084 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Leiden University Medical Center is the lead sponsor of 334 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The PROSPERA-program
Other: PROSPERA-program
Primary cardiovascular care-as-usual, according to national and international applicable guidelines.
The PROSPERA-program consists of the following components: 1. Health care provider training and education about U-Prevent and cardiovascular risk communication. 2. Risk stratification: proactive selection of cardiovascular patients through the PROSPERA-empanelment procedure - for the population with increased cardiovascular risk, prior to consultation. 3. Decision support tools: use of the Lifestylecheck and the U-Prevent clinical decision support tool to guide motivated shared decision making towards appropriate care matched to the care complexity of the patient - for the individual patient, during consultation.
The proportion of individuals who have achieved all protocol-defined cardiovascular prevention goals.
Protocol-defined treatment goals are in line with local prevention targets (including treatment targets such as Systolic Blood Pressure, LDL-cholesterol, Antithrombotic therapy, HbA1c, SGTL2 inhibitors and/or GLP1-receptor agonists). The sample size is based on the minimum number of subjects (patients) who will complete the component of the intervention conducted during consultation (= the clinical decision tools). A subset will receive additional questionnaires. The primary outcome will be compared among the complete study population as well as in the subgroup.
Time frame: At 0 and 18 months
Perceived shared decision making (in subset only)
9-item Shared Decision Making Questionnaire (SDM-Q-9)
Time frame: immediately after the intervention
Perceived shared decision making (in subset only)
Patient interviews (qualitative)
Time frame: immediately after the intervention
Decisional Conflict (in subset only)
The Decisional Conflict Scale (DCS)
Time frame: immediately after the intervention
Implementation outcome: fidelity
Percentage of target population that has received the U-Prevent component of the PROSPERA-program during the study duration as measured by the U-Prevent logbook.
Time frame: At month 4 and 10
Implementation outcome: fidelity
Fidelity checklist by HCPs .
Time frame: At month 4 and 10
Implementation outcome: penetration
The number of health care professionals who deliver the PROSPERA-program on an individual patient level (component 2) divided by the number of health care professionals who are expected to deliver this service.
Time frame: At month 10
Healthcare professional's satisfaction on usability of the PROSPERA-program
System Usability Scale
Time frame: At month 10
Cost-effectiveness
Cost-effectiveness of the PROSPERA-program in Quality-Adjusted Life Years (QALYs) as calculated in a cost-effectiveness analysis
Time frame: immediately after the intervention and at month 18
Plan to share: No — Due to the nature of the study, blinding is not possible. Therefore, the data might contain privacy sensitive information and only restricted access can be granted for parts of the collected data. It has yet to be decided which data can be acquired through restricted access.
No publications or documents are linked to this record.
Started Feb 2025 (actual). Primary completion is estimated for Oct 2026, 19 months after the start.
Of 1,077 non-industry interventional studies with no phase under Cardiovascular Diseases, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 19 months is below that.
Counting every sponsor, half of 1,216 studies reached it within 26 months; a quarter within 12 and three quarters within 49.
Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
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