NCT04912739

Brief Summary

The County Council of Region Skåne, Sweden, has recently initiated Targeted Health Dialogues in primary care. The prevention program includes health dialogues provided by specially trained personnel, collection of clinical and laboratory data as well as questionnaire data on, e.g., individual health and health behaviors. So far, it enrolls all 40-year old Swedish and foreign-born inhabitants in the county and it will also include all 50- and 60-year old persons within a near future. A research project will be integrated within the program where the collected data will be linked, on the individual level, to national and regional data on hospital admissions, clinical diagnoses from specialist clinics and primary care, causes of death, and prescriptions. The individual linkages will also include population data on sociodemographic characteristics, neighborhood of residence and family relations. Blood samples will be collected for analyses of molecular biomarkers. The research project will examine associations between potential predictors and future risk of cardiovascular diseases and other serious diseases, such as cancer, and also whether the effect of the prevention program is modified by these potential predictors. The effect of the intervention will be examined, and whether the protocol needs to be modified in order to develop more precise and personalized medicine.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18,000

participants targeted

Target at P75+ for all trials

Timeline
179mo left

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Oct 2020Dec 2040

Study Start

First participant enrolled

October 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 3, 2021

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2040

Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

10.3 years

First QC Date

April 23, 2021

Last Update Submit

June 24, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Effect of targeted health dialogues on CVD incidence

    The short- and long-term effect of targeted health dialogues on incidence of CVD events, its comorbidity and CVD-related deaths in the participants compared to a general population cohort and historical controls.

    2035

  • Effect of targeted health dialogues on incidence of cancer and other serious diseases

    The short- and long-term effect of targeted health dialogues on incidence of cancer and other serious diseases in the participants compared to a general population cohort and historical controls.

    2035

Secondary Outcomes (14)

  • Modification by individual characteristics

    2035

  • Association between risk factors and disease incidence

    2035

  • Identification of molecular biomarkers

    2035

  • Public health profile of middle-aged citizens in Sweden's southernmost county

    2035

  • Associations between dental and general health

    2035

  • +9 more secondary outcomes

Interventions

Before the targeted health dialogue, the participants fill in a questionnaire about health behaviors, background characteristics and self-rated health. Samples for blood glucose and total cholesterol are taken. BMI, waist-to-hip ratio and blood pressure are measured. The results are summoned in a "health curve", which is discussed with specially trained healthcare personnel in a Targeted heath dialogue. In a sub-group, blood samples are collected for molecular analyses.

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

In Sweden, most people are listed at one healthcare center. The study population consists of all listed 40-, 50-, 60-year, and 70-year-old patients that perform a targeted health dialogue and consent to take part in the research study.

You may qualify if:

  • , 50-, 60-, and 70-year old men and women
  • Listed at a healthcare center in Skåne county

You may not qualify if:

  • \* Inability to understand the written study information and give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Primary Health Care Research, Lund University and Region Skåne

Malmo, Skåne County, 20502, Sweden

RECRUITING

Related Publications (2)

  • Nymberg P, Milos-Nymberg V, Grundberg A, Oscarson N, Stenman E, Sundquist K. Exploring the link between self-rated poor oral health and cardiovascular risk: a cross-sectional study using SCORE2. BMC Oral Health. 2025 Feb 24;25(1):298. doi: 10.1186/s12903-025-05671-6.

  • Stenman E, Borgstrom Bolmsjo B, Grundberg A, Sundquist K. Health determinants among participants in targeted health dialogues offered to all 40-year-old individuals in a metropolitan region of 1.4 million people. Scand J Prim Health Care. 2025 Mar;43(1):24-35. doi: 10.1080/02813432.2024.2385547. Epub 2024 Aug 1.

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Health BehaviorCardiovascular DiseasesNeoplasms

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Kristina Sundquist, PhD, MD

    Center for Primary Health Care Research, Department of Clinical Sciences Malmö, Lund University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristina Sundquist, PhD, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2021

First Posted

June 3, 2021

Study Start

October 1, 2020

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2040

Last Updated

June 25, 2025

Record last verified: 2025-06

Locations