Using the Visualization for Lifestyle Change in Patients At Risk of Cardiovascular Diseases

Not Applicable

Completed

• Conditions: Cardiovascular Diseases; Behaviour Change; Heart Diseases; Continuous Glucose Monitoring; Lifestyle; Coronary Artery Disease; Coronary Heart Disease; Visual Analytics; CGM
• Interventions: Diagnostic Test: Visualization; Device: CGM

• Registration Number: NCT06226948
• Lead Sponsor: University Maribor

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-01-17
• Study First Submitted QC: 2024-01-17
• Study First Posted: 2024-01-26
• Study Start: 2024-05-06
• Primary Completion: 2024-12-06
• Study Completion: 2024-12-06
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• individuals ages more than 40 years
• without serious disease progression
• at least one risk factor for CVDs

Exclusion Criteria

• individuals younger than 40 years
• with serious disease progression
• without risk factor for CVDs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group 3	Visualization	Participants will use a visualization of CVDs risk.
Intervention group 1	CGM	Participants will use a continuous blood glucose monitoring and visualization of CVDs risk.
Intervention group 1	Visualization	Participants will use a continuous blood glucose monitoring and visualization of CVDs risk.
Intervention group 2	CGM	Participants will use a continuous blood glucose monitoring.

Primary Outcome Measures

Name	Time	Method
Assessment of change of lifestyle.	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.	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.
Assessment of person-centred care.	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.	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.
Systematic Coronary Risk Evaluation 2 risk	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.	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.

Secondary Outcome Measures

Name	Time	Method
Assessment in Biological age	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.	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.

Trial Locations

Locations (1)

Faculty of Health Sciences; 🇸🇮 Maribor, Slovenia