Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06593704

Proactive Population Health Management of Cardiovascular Disease in Primary Care Using 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.

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).

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Cardiovascular Diseases

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Public Health and Primary Care

The Hague, South Holland, 2511PL, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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')

Treatment and study plan

PROSPERA-program

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Perceived shared decision making (in subset only)

    Time frame: immediately after the intervention

    9-item Shared Decision Making Questionnaire (SDM-Q-9)

  2. Perceived shared decision making (in subset only)

    Time frame: immediately after the intervention

    Patient interviews (qualitative)

  3. Decisional Conflict (in subset only)

    Time frame: immediately after the intervention

    The Decisional Conflict Scale (DCS)

  4. Implementation outcome: fidelity

    Time frame: At month 4 and 10

    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.

  5. Implementation outcome: fidelity

    Time frame: At month 4 and 10

    Fidelity checklist by HCPs

    .

  6. Implementation outcome: penetration

    Time frame: At month 10

    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.

  7. Healthcare professional's satisfaction on usability of the PROSPERA-program

    Time frame: At month 10

    System Usability Scale

  8. Cost-effectiveness

    Time frame: immediately after the intervention and at month 18

    Cost-effectiveness of the PROSPERA-program in Quality-Adjusted Life Years (QALYs) as calculated in a cost-effectiveness analysis

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

  • UMC Utrecht

Registry information

Official study title

Proactive Population Health Management of Cardiovascular Disease in Primary Care Using a Multilevel Guideline Adherence Toolkit (the PROSPERA-program).

Acronym: PROSPERA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.