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

NCT ID: NCT06226948

Last Updated: 2025-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-06

Study Completion Date

2024-12-06

Brief Summary

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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

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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.

Conditions

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Cardiovascular Diseases Coronary Artery Disease Heart Diseases Coronary Heart Disease Visual Analytics Continuous Glucose Monitoring CGM Lifestyle Behaviour Change

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention group 1

Participants will use a continuous blood glucose monitoring and visualization of CVDs risk.

Group Type EXPERIMENTAL

CGM

Intervention Type DEVICE

Participants will wear CGM monitors for 10 days.

Visualization

Intervention Type DIAGNOSTIC_TEST

Enriched visualization of SCORE2 CVD risk.

Intervention group 2

Participants will use a continuous blood glucose monitoring.

Group Type EXPERIMENTAL

CGM

Intervention Type DEVICE

Participants will wear CGM monitors for 10 days.

Intervention group 3

Participants will use a visualization of CVDs risk.

Group Type EXPERIMENTAL

Visualization

Intervention Type DIAGNOSTIC_TEST

Enriched visualization of SCORE2 CVD risk.

Control group

No intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CGM

Participants will wear CGM monitors for 10 days.

Intervention Type DEVICE

Visualization

Enriched visualization of SCORE2 CVD risk.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Intervention 1 Intervention 2 Intervention 1 Intervention 3

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Maribor

OTHER

Sponsor Role lead

Responsible Party

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Adrijana Svensek

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Health Sciences

Maribor, , Slovenia

Site Status

Countries

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Slovenia

References

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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.

Reference Type BACKGROUND
PMID: 25253039 (View on PubMed)

Related Links

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Other Identifiers

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05a/2I-2023

Identifier Type: -

Identifier Source: org_study_id

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