Targeted Health Dialogues in Primary Care

Targeted Health Dialogues in Primary Care: Lifestyle Screening and Molecular Profiling for a Healthier Life

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Cancer; Risk Factors; Health Behaviors; Serious Diseases
• Intervention / Treatment: Behavioral: Targeted health dialogues

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.

• Study Type: Observational
• Enrollment (Estimated): 18000

Contacts and Locations

• Study Contact: Name: Kristina Sundquist, PhD, MD; Phone Number: +46 (0)40 391 376; Email: kristina.sundquist@med.lu.se
• Study Contact Backup: Name: Emelie Stenman, PhD; Phone Number: +46 (0)702 900 920; Email: emelie.stenman@med.lu.se

Study Locations

• Sweden
  • Skåne
    • Malmö, Skåne, Sweden, 20502
      • Recruiting
      • Center for Primary Health Care Research, Lund University and Region Skåne
      • Contact: Kristina Sundquist, PhD, MD; Phone Number: +46 (0)40 391 376; Email: kristina.sundquist@med.lu.se
      • Contact: Emelie Stenman, PhD; Phone Number: +46 (0)702 900 920; Email: emelie.stenman@med.lu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modification by individual characteristics	Modification of possible associations between targeted health dialogues and future CVD, cancer, other serious diseases and preterm death by individual characteristics (e.g., sociodemographic factors)	2035
Association between risk factors and disease incidence	Associations between risk factors/combination of risk factors (lifestyle-related, metabolic, psychosocial and familial) at baseline and incidence of CVD, cancer, other serious diseases and preterm death.	2035
Identification of molecular biomarkers	The ability of biological aging, epigenetic changes and genetic and metabolomic profiles to predict CVD, cancer, other serious diseases and preterm death as well as the effect of targeted health dialogues.	2035
Associations between dental and general health	Associations between dental health at baseline and incidence of CVD, cancer, other serious diseases and preterm death.	2035
Validation of the targeted health dialogue method	Validity and reliability of the questionnaire and targeted health dialogue method	2035
Health economy	Costs related to the targeted health dialogues versus individual and societal gains.	2035
The effect of targeted health dialogues on health behaviors and self-rated health		2035
Do targeted health dialogues reach all societal groups?		2035
Can other lifestyle interventions influence the effect of targeted health dialogues?		2035
Public health profile of middle-aged citizens in Sweden's southernmost county	Level of physical activity and sedentary behavior, intake of healthy/unhealthy food, alcohol consumption, smoking habits, stress, psychological well-being, blood glucose, cholesterol, BMI, waist-hip ratio. Comparisons between subgroups: age, sex, sociodemography, previous diagnoses.	2035
Follow-up of samples taken after the targeted health dialogues.	Which samples and tests were taken as a result of the targeted health dialogues?	2035
Do the the targeted health dialogues influence care seeking?	Evaluation of new search patterns due to the targeted health dialogues.	2035
Obstacles and motivators for physical activity	What obstacles and motivators for physical activity do inactive people experience?	2035
Effect of targeted health dialogues on blood metabolites	Do targeted health dialogues affect food-related metabolites in the blood?	2035

Collaborators and Investigators

• Sponsor: Region Skane
• Investigators: Principal Investigator: Kristina Sundquist, PhD, MD, Center for Primary Health Care Research, Department of Clinical Sciences Malmö, Lund University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2040

Study Registration Dates

• First Submitted: April 23, 2021
• First Submitted That Met QC Criteria: May 31, 2021
• First Posted (Actual): June 3, 2021

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 24, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 2020-02689

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No