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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06226948
• Other study ID #: 05a/2I-2023
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 6, 2024
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University Maribor
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• CGM
• Continuous Glucose Monitoring
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Lifestyle
• Myocardial Ischemia

Intervention

Device:
• CGM
Participants will wear CGM monitors for 10 days.

Diagnostic Test:
• Visualization
Enriched visualization of SCORE2 CVD risk.

Locations

Country	Name	City	State
Slovenia	Faculty of Health Sciences	Maribor

Sponsors (1)

Lead Sponsor	Collaborator
University Maribor

Country where clinical trial is conducted

Slovenia, 

References & Publications (1)

Darviri C, Alexopoulos EC, Artemiadis AK, Tigani X, Kraniotou C, Darvyri P, Chrousos GP. The Healthy Lifestyle and Personal Control Questionnaire (HLPCQ): a novel tool for assessing self-empowerment through a constellation of daily activities. BMC Public Health. 2014 Sep 24;14:995. doi: 10.1186/1471-2458-14-995. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.
Primary	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.	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.
Primary	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.	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.
Secondary	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.	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.

External Links

•   Centre for Person-Centred Practice Research
•   European Society of Cardiology