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

L

Leiden University Medical Center (LUMC)

Status

Not yet enrolling

Conditions

Cardiovascular Diseases

Treatments

Other: PROSPERA-program

Study type

Interventional

Funder types

Other

Identifiers

NCT06593704
10140302110018 (Other Grant/Funding Number)
23-3050

Details and patient eligibility

About

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).

Enrollment

848 estimated patients

Sex

All

Ages

40 to 90 years old

Volunteers

No Healthy Volunteers

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')

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

848 participants in 2 patient groups

PROSPERA
Experimental group
Description:
The PROSPERA-program
Treatment:
Other: PROSPERA-program
Control
No Intervention group
Description:
Primary cardiovascular care-as-usual, according to national and international applicable guidelines.

Trial contacts and locations

0

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Central trial contact

Rimke C Vos; Vera AM Bongaerts

Data sourced from clinicaltrials.gov

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