Cardiovascular DiseasesPROSPERANCT06593704
Proactive Population Health Management of Cardiovascular Disease in Primary Care Using the PROSPERA-program.
A study testing PROSPERA-program in people with Cardiovascular Diseases, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- PROSPERA-program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 848 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Feb 2025to 15 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 40 years and ≤ 90 years
- Patient in a primary care practice enrolled in this study
- Included in the cardiovascular disease (CVD), increased vascular risk (IVR) or diabetes mellitus (DM) Dutch Integrated Care programs
- Additional criteria for subgroup that receives questionnaires: able to communicate in the Dutch and/or English language
Who cannot join
- Patients with Diabetes Mellitus type I
- Patients receiving palliative care
- Patients with any form of cognitive impairment diseases such as Dementia or Alzheimer
- Patients who are treated in other Integrated Care programs because of their frailty (e.g. elderly who are treated in the 'Kwetsbare Ouderen Chronische Zorgprogramma')
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Department of Public Health and Primary Care
The Hague, South Holland, 2511PL
About this study
Official title: Proactive Population Health Management of Cardiovascular Disease in Primary Care Using a Multilevel Guideline Adherence Toolkit (the PROSPERA-program).
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.
Read more
The main question it aims to answer is:
- Does the cardiovascular risk profile improve for patients using the PROSPERA-program?
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:
- Receive a consultation with their general practitioner or practice nurse according to the PROSPERA-program.
- Have their routinely collected healthcare data used for evaluation.
- Be asked to complete a questionnaire or participate in an interview (for a subset of patients).
- Conditions
- Cardiovascular Diseases
- Being tested
- PROSPERA-program
- Keywords
- Primary Care, Population Health Management, Implementation
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROSPERA-programOther
The PROSPERA-program consists of the following components:
- Health care provider training and education about U-Prevent and cardiovascular risk communication.
- Risk stratification: proactive selection of cardiovascular patients through the PROSPERA-empanelment procedure - for the population with increased cardiovascular risk, prior to consultation.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| PROSPERA | Experimental | The PROSPERA-program Receives: Other: PROSPERA-program |
| Control | No intervention | Primary cardiovascular care-as-usual, according to national and international applicable guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 0 and 18 months
Secondary outcomes (8)
Perceived shared decision making (in subset only)
9-item Shared Decision Making Questionnaire (SDM-Q-9)
Measured: immediately after the intervention
Perceived shared decision making (in subset only)
Patient interviews (qualitative)
Measured: immediately after the intervention
Decisional Conflict (in subset only)
The Decisional Conflict Scale (DCS)
Measured: 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.
Measured: At month 4 and 10
Implementation outcome: fidelity
Fidelity checklist by HCPs
.
Measured: 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.
Measured: At month 10
Healthcare professional's satisfaction on usability of the PROSPERA-program
System Usability Scale
Measured: At month 10
Cost-effectiveness
Cost-effectiveness of the PROSPERA-program in Quality-Adjusted Life Years (QALYs) as calculated in a cost-effectiveness analysis
Measured: immediately after the intervention and at month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start17 Feb 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 848 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht
- Responsible party
- Principal investigator, rcvos, Leiden University Medical Center
- Investigators
- Rimke C Vos, Principal investigator, LUMCMattijs E Numans, Principal investigator, LUMCJannick AN Dorresteijn, Principal investigator, UMC UtrechtHendrikus JA van Os, Principal investigator, LUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593704
- Sponsor's protocol ID
- 23-3050
- Other IDs
- 10140302110018
- Acronym
- PROSPERA
- Status last verified
- Sep 2026
- First submitted
- 29 Aug 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proactive Population Health Management of Cardiovascular Disease in Primary Care Using a Multilevel Guideline Adherence Toolkit (the PROSPERA-program).
- ClinicalTrials.gov ID
- NCT06593704
- Acronym / sponsor ID
- PROSPERA / 23-3050
- Conditions
- Cardiovascular Diseases
- Keywords
- Primary Care, Population Health Management, Implementation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 848 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- UMC Utrecht
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- 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.
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:
- Does the cardiovascular risk profile improve for patients using the PROSPERA-program?
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:
- Receive a consultation with their general practitioner or practice nurse according to the PROSPERA-program.
- Have their routinely collected healthcare data used for evaluation.
- Be asked to complete a questionnaire or participate in an interview (for a subset of patients).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROSPERA | Experimental | Other: PROSPERA-programThe PROSPERA-program |
| Control | No intervention | –Primary cardiovascular care-as-usual, according to national and international applicable guidelines. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 40 years and ≤ 90 years
- Patient in a primary care practice enrolled in this study
- Included in the cardiovascular disease (CVD), increased vascular risk (IVR) or diabetes mellitus (DM) Dutch Integrated Care programs
- Additional criteria for subgroup that receives questionnaires: able to communicate in the Dutch and/or English language
Key exclusion criteria (4 listed)
- Patients with Diabetes Mellitus type I
- Patients receiving palliative care
- Patients with any form of cognitive impairment diseases such as Dementia or Alzheimer
- Patients who are treated in other Integrated Care programs because of their frailty (e.g. elderly who are treated in the 'Kwetsbare Ouderen Chronische Zorgprogramma')
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 |
|---|---|---|
| PROSPERA-programThe 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. | Other | PROSPERA |
Primary outcome
The proportion of individuals who have achieved all protocol-defined cardiovascular prevention goals.
Time frame: At 0 and 18 months
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.
8 secondary outcomes
Perceived shared decision making (in subset only)
Time frame: immediately after the intervention
Perceived shared decision making (in subset only)
Time frame: immediately after the intervention
Decisional Conflict (in subset only)
Time frame: immediately after the intervention
Implementation outcome: fidelity
Time frame: At month 4 and 10
Implementation outcome: fidelity
Time frame: At month 4 and 10
Implementation outcome: penetration
Time frame: At month 10
Healthcare professional's satisfaction on usability of the PROSPERA-program
Time frame: At month 10
Cost-effectiveness
Time frame: immediately after the intervention and at month 18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: 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.
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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.
Rimke C Vos principal investigator
LUMC
Mattijs E Numans principal investigator
LUMC
Jannick AN Dorresteijn principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROSPERA-program in people with Cardiovascular Diseases, run by Leiden University Medical Center at 1 site in Netherlands.
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 4 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
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?
The proportion of individuals who have achieved all protocol-defined cardiovascular prevention goals. (time frame: At 0 and 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2026.