Targeted Health Dialogues in Primary Care

NCT ID: NCT04912739

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 18000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2040-12-31

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.

Detailed Description

The County Council of Region Skåne, the third most populous region in Sweden with 1.4 million inhabitants, has recently initiated Targeted Health Dialogues in primary care with the ultimate goal to improve cardiovascular health in the entire population in Skåne. Targeted health dialogues have previously been proven to improve health behaviors and risk factors and decrease the incidence of cardiovascular disease and mortality. The prevention program includes, in addition to the health dialogues provided by specially trained personnel, collection of clinical and laboratory data (e.g. blood pressure, BMI, waist hip ratio, lipids, fasting blood glucose) as well as detailed questionnaire data on, e.g., individual health and symptoms, family history, diet, physical activity, alcohol and smoking. 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. The County Council and the Ethical Review Board have granted permission to integrate a research project within the program where collected data will be linked, at 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. In addition to the collection and linkages of these data, blood samples will be collected for analyses of molecular biomarkers. The research project will allow for examining associations between a number of potential predictors and future risk of cardiovascular disease 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.

Conditions

Health Behaviors; Risk Factors; Cardiovascular Diseases; Cancer; Serious Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Targeted health dialogues

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 40-, 50-, 60-, and 70-year old men and women
• Listed at a healthcare center in Skåne county

Exclusion Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristina Sundquist, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Malmo, Skåne County, Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Kristina Sundquist, PhD, MD

Role: CONTACT

kristina.sundquist@med.lu.se

+46 (0)40 391 376

Emelie Stenman, PhD

Role: CONTACT

emelie.stenman@med.lu.se

+46 (0)702 900 920

Facility Contacts

Kristina Sundquist, PhD, MD

Role: primary

kristina.sundquist@med.lu.se

+46 (0)40 391 376

Emelie Stenman, PhD

Role: backup

emelie.stenman@med.lu.se

+46 (0)702 900 920

References

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.

Reference Type: DERIVED

PMID: 39994610 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39091122 (View on PubMed)

Other Identifiers

2020-02689

Identifier Type: -

Identifier Source: org_study_id