Targeted Health Dialogues in Primary Care
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-70
SponsorRegion Skane
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
40-, 50-, 60-, and 70-year old men and women
Listed at a healthcare center in Skåne county
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Targeted health dialogues
BehavioralBefore 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
20352
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.
Time frame
2035Secondary outcomes
1
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)
Time frame
20352
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.
Time frame
20353
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.
Time frame
20354
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.
Time frame
2035Sponsors and contacts
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Source ClinicalTrials.gov