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Can a toolkit help family doctors catch heart risk sooner?

NCT ID NCT06593704

Disease control Sponsor: Leiden University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing whether a structured primary care program can help adults aged 40 to 90 with higher heart or diabetes risk reach recommended prevention targets. The program trains doctors and nurses, uses routine data to flag at-risk patients before visits, and provides decision tools to guide shared choices about treatment. The trial compares this approach with standard care and also looks at how well it fits into daily clinic workflows.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a primary care program combining clinician training, proactive risk screening, and shared decision-making tools
What this could lead to
If it works, this could give primary care practices a practical way to find and treat people at higher risk of heart disease and diabetes earlier, before problems become serious.
What could go wrong
This is a large but non-drug study, so its success depends on whether busy clinics can consistently follow the new workflow. Results may not carry over to other health systems or countries.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 848 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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')

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Public Health and Primary Care

    The Hague, South Holland, 2511PL, Netherlands

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