Clinical trial NCT04912739: Targeted Health Dialogues in Primary Care
Official title: Targeted Health Dialogues in Primary Care: Lifestyle Screening and Molecular Profiling for a Healthier Life
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Health Behaviors
Risk Factors
Cardiovascular Diseases
Cancer
Serious Diseases
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 18000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Effect of targeted health dialogues on CVD incidence
timeFrame: 2035
measure: Effect of targeted health dialogues on incidence of cancer and other serious diseases
timeFrame: 2035
Secondary outcomes:
measure: Modification by individual characteristics
timeFrame: 2035
measure: Association between risk factors and disease incidence
timeFrame: 2035
measure: Identification of molecular biomarkers
timeFrame: 2035
measure: Public health profile of middle-aged citizens in Sweden's southernmost county
timeFrame: 2035
measure: Associations between dental and general health
timeFrame: 2035
measure: Validation of the targeted health dialogue method
timeFrame: 2035
measure: Health economy
timeFrame: 2035
measure: The effect of targeted health dialogues on health behaviors and self-rated health
timeFrame: 2035
measure: Do targeted health dialogues reach all societal groups?
timeFrame: 2035
measure: Can other lifestyle interventions influence the effect of targeted health dialogues?
timeFrame: 2035
measure: Follow-up of samples taken after the targeted health dialogues.
timeFrame: 2035
measure: Do the the targeted health dialogues influence care seeking?
timeFrame: 2035
measure: Obstacles and motivators for physical activity
timeFrame: 2035
measure: Effect of targeted health dialogues on blood metabolites
timeFrame: 2035
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Center for Primary Health Care Research, Lund University and Region Skåne
state: Skåne
Study officials:
affiliation: Center for Primary Health Care Research, Department of Clinical Sciences Malmö, Lund University
name: Kristina Sundquist, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: