Targeted Health Dialogues in Primary Care

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04912739
• Other study ID #: 2020-02689
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: December 31, 2035

Study information

• Verified date: April 2024
• Source: Region Skane
• Contact: Kristina Sundquist, PhD, MD
• Phone: +46 (0)40 391 376
• Email: kristina.sundquist[@]med.lu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 18000
• Est. completion date: December 31, 2035
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Cardiovascular Diseases
• Health Behaviors
• Risk Factors

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Sweden	Center for Primary Health Care Research, Lund University and Region Skåne	Malmö	Skåne

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Associations between dental and general health	Associations between dental health at baseline and incidence of CVD, cancer, other serious diseases and preterm death.	2035
Secondary	Validation of the targeted health dialogue method	Validity and reliability of the questionnaire and targeted health dialogue method	2035
Secondary	Health economy	Costs related to the targeted health dialogues versus individual and societal gains.	2035
Secondary	The effect of targeted health dialogues on health behaviors and self-rated health		2035
Secondary	Do targeted health dialogues reach all societal groups?		2035
Secondary	Can other lifestyle interventions influence the effect of targeted health dialogues?		2035
Secondary	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
Secondary	Do the the targeted health dialogues influence care seeking?	Evaluation of new search patterns due to the targeted health dialogues.	2035
Secondary	Obstacles and motivators for physical activity	What obstacles and motivators for physical activity do inactive people experience?	2035
Secondary	Effect of targeted health dialogues on blood metabolites	Do targeted health dialogues affect food-related metabolites in the blood?	2035