Clinical trial NCT06226948: Using the Visualization for Lifestyle Change in Patients At Risk of Cardiovascular Diseases
Official title: Using the Visualization for Lifestyle Change in Patients At Risk of Cardiovascular Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Coronary Artery Disease
Heart Diseases
Coronary Heart Disease
Visual Analytics
Continuous Glucose Monitoring
CGM
Lifestyle
Behaviour Change
Lead sponsor: University Maribor
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of change of lifestyle.
timeFrame: 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.
measure: Assessment of person-centred care.
timeFrame: 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.
measure: Systematic Coronary Risk Evaluation 2 risk
timeFrame: 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 outcomes:
measure: Assessment in Biological age
timeFrame: 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.
Other outcomes:
Locations:
city: Maribor
country: Slovenia
facility: Faculty of Health Sciences
Study officials:
References:
citation: 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.