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Targeted Health Dialogues in Primary Care

Recruiting
Conditions
Health Behaviors
Serious Diseases
Cardiovascular Diseases
Risk Factors
Cancer
Registration Number
NCT04912739
Lead Sponsor
Region Skane
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
18000
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Effect of targeted health dialogues on CVD incidence2035

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.

Effect of targeted health dialogues on incidence of cancer and other serious diseases2035

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.

Secondary Outcome Measures
NameTimeMethod
Association between risk factors and disease incidence2035

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.

Identification of molecular biomarkers2035

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.

Associations between dental and general health2035

Associations between dental health at baseline and incidence of CVD, cancer, other serious diseases and preterm death.

Can other lifestyle interventions influence the effect of targeted health dialogues?2035
Obstacles and motivators for physical activity2035

What obstacles and motivators for physical activity do inactive people experience?

Modification by individual characteristics2035

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)

Public health profile of middle-aged citizens in Sweden's southernmost county2035

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.

Do targeted health dialogues reach all societal groups?2035
Validation of the targeted health dialogue method2035

Validity and reliability of the questionnaire and targeted health dialogue method

The effect of targeted health dialogues on health behaviors and self-rated health2035
Effect of targeted health dialogues on blood metabolites2035

Do targeted health dialogues affect food-related metabolites in the blood?

Health economy2035

Costs related to the targeted health dialogues versus individual and societal gains.

Do the the targeted health dialogues influence care seeking?2035

Evaluation of new search patterns due to the targeted health dialogues.

Follow-up of samples taken after the targeted health dialogues.2035

Which samples and tests were taken as a result of the targeted health dialogues?

Trial Locations

Locations (1)

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

🇸🇪

Malmö, Skåne, Sweden

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