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

January 21, 2025 updated by: Adrijana Svensek, University Maribor
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Maribor, Slovenia
        • Faculty of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
No intervention.
Experimental: Intervention group 1
Participants will use a continuous blood glucose monitoring and visualization of CVDs risk.
Diagnostic test: Visualization
Enriched visualization of SCORE2 CVD risk.
Other Names:
  • Intervention 1
  • Intervention 3
Device: CGM
Participants will wear CGM monitors for 10 days.
Other Names:
  • Intervention 1
  • Intervention 2
Experimental: Intervention group 2
Participants will use a continuous blood glucose monitoring.
Device: CGM
Participants will wear CGM monitors for 10 days.
Other Names:
  • Intervention 1
  • Intervention 2
Experimental: Intervention group 3
Participants will use a visualization of CVDs risk.
Diagnostic test: Visualization
Enriched visualization of SCORE2 CVD risk.
Other Names:
  • Intervention 1
  • Intervention 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of change of 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.

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.
Assessment of person-centred care.
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.
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.
Systematic Coronary Risk Evaluation 2 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment in Biological age
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Maribor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2024

Primary Completion (Actual)

December 6, 2024

Study Completion (Actual)

December 6, 2024

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

January 17, 2024

First Posted (Actual)

January 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 21, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05a/2I-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The anonymity of all research participants will be guaranteed throughout the research. Only the researcher involved will have access to the anonymised data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Diseases

Clinical Trials on Visualization

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe