An interventional study of CGM and Visualization in Cardiovascular Diseases, Coronary Artery Disease and Heart Diseases, sponsored by University Maribor. Completed at 1 site in Slovenia. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-24.
Sponsored by University Maribor · Not applicable, Interventional, and Supportive care
In the framework of PhD research, the investigators will present a visualization of estimation of CVDs risk and the possibility of monitoring blood glucose levels in real-time. Based on the results, the investigators will assess the association of these with lifestyle change. The findings highlight the need for sufficiently reliable and high-quality evaluations of visualizations, technologies or applications used in the family medicine.
The investigators reviewed the existing literature and found little research on the use of Continuous Glucose Monitoring (CGM) and visualization of SCORE2 prognostic model in healthy populations and how they can influence lifestyle change. The investigators will conduct a randomised control trial with 3 intervention groups and 1 control gropu. The investigators also found that primary care nurses are still using paper-based methods to calculate CVDs by using colour-coded charts. Therefore, the investigators will use the visual tool of the SCORE2 scale to identify possible increased participants motivation using visualization. The investigators will also confirm or refute lifestyle change by calculating biological age.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's enrollment of 120 is close to the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →University Maribor is the lead sponsor of 11 studies on the registry; 4 are open to participants now.
Compared within Coronary Artery Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Cardiovascular Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will use a continuous blood glucose monitoring and visualization of CVDs risk.
Device: CGM · Diagnostic Test: Visualization
Participants will use a continuous blood glucose monitoring.
Device: CGM
Participants will use a visualization of CVDs risk.
Diagnostic Test: Visualization
No intervention.
Participants will wear CGM monitors for 10 days.
Also known as: Intervention 1, Intervention 2
Enriched visualization of SCORE2 CVD risk.
Also known as: Intervention 1, Intervention 3
Assessment of change of lifestyle.
Change of lifestyle will be assessed using the Healthy Lifestyle and Personal Control Questionnaire from Darviri, et al., 2014. The goal of this questionnaire is to detect and quantify lifestyle patterns that reflect health empowerment and for assessing the efficacy of future health-promoting interventions to improve individuals' lifestyles and wellbeing. The assessment is based on a 4-point Likert scale (1 = never or rarely, 2 = sometimes, 3 = often and 4 = always). The final calculation of lifestyle is based on the sum of the dimensions. The dimensions can also be compared individually with each other at the final stage to determine which dimension has experienced the greatest change in lifestyle. The minimum possible score is 31, indicating no change in lifestyle, and the maximum possible score is 90, indicating the greatest change in lifestyle.
Time frame: Change in Healthy Lifestyle and Personal Control Questionnaire score will be assessed at the enrolment of the participants followed by the examination in the period of up to 6 months after the enrolment.
Assessment of person-centred care.
The Person-Centred Practice Inventory - Service User consists of 20 items measuring participants agreement with statements related to perceptions of person-centred care and includes 5 constructs: working with participants beliefs and values, shared decision making, compassionate presence and holistic care.The score is based on a 5-point Likert scale. The lowest level of participants agreement is 20 and the highest level is 100.
Time frame: The Person-Centred Practice Inventory - Service User score will be assessed at the enrolment of the participants followed by the examination in the period of up to 6 months after the enrolment.
Systematic Coronary Risk Evaluation 2 risk
Systematic Coronary Risk Evaluation 2 is designed to calculate the risk of CVD according to the Systematic Coronary Risk Evaluation 2 prognostic model (ESC, 2022).The higher the percentage, the higher the risk.
Time frame: Change in Systematic Coronary Risk Evaluation 2 score will be assessed at the enrolment of the participants followed by the examination in the period of up to 6 months after the enrolment.
Assessment in Biological age
Biological age tells us whether we are physiologically younger or older than our chronological age.The scale depends on each individual - it's individual. The closer the biological age result is to the chronological one, the better the result.
Time frame: Change in Biological age will be assessed at the enrolment of the participants followed by the examination in the period of up to 3 and 6 months after the enrolment.
Plan to share: No — The anonymity of all research participants will be guaranteed throughout the research. Only the researcher involved will have access to the anonymised data.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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University Maribor