Proactive Population Health Management of Cardiovascular Disease in Primary Care Using the PROSPERA-program.

NCT ID: NCT06593704

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 848 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-17
• Study Completion Date: 2026-07-09

Brief 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.

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).

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PROSPERA

The PROSPERA-program

Group Type: EXPERIMENTAL

PROSPERA-program

Intervention Type: OTHER

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.

Control

Primary cardiovascular care-as-usual, according to national and international applicable guidelines.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PROSPERA-program

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.

Intervention Type: OTHER

Eligibility Criteria

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')

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UMC Utrecht

OTHER

Sponsor Role: collaborator

Leiden University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

rcvos

Principal Investigator R.C. Vos

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rimke C Vos

Role: PRINCIPAL_INVESTIGATOR

LUMC

Mattijs E Numans

Role: PRINCIPAL_INVESTIGATOR

LUMC

Jannick AN Dorresteijn

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Hendrikus JA van Os

Role: PRINCIPAL_INVESTIGATOR

LUMC

Locations

Department of Public Health and Primary Care

The Hague, South Holland, Netherlands

Countries

Netherlands

Other Identifiers

10140302110018

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

23-3050

Identifier Type: -

Identifier Source: org_study_id