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Cardiovascular DiseasesNCT06226948

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

A study testing CGM and Visualization in people with Cardiovascular Diseases and Coronary Artery Disease, run by University Maribor at 1 site in Slovenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 years and olderHealthy volunteers can take part
What is being tested?
CGM and Visualization
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteSlovenia
Study dates
6 May 2024to 6 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Slovenia1 site

  • Faculty of Health Sciences

    Maribor

Other trials in Slovenia

About this study

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.

Read the 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.

Being tested
CGM, Visualization
Medical subject headings
Cardiovascular Diseases, Coronary Artery Disease, Heart Diseases, Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CGMDevice

    Also called Intervention 1, Intervention 2

    Participants will wear CGM monitors for 10 days.

  • VisualizationDiagnostic test

    Also called Intervention 1, Intervention 3

    Enriched visualization of SCORE2 CVD risk.

Study groups in NCT06226948
Study groupRoleWhat they receive
Intervention group 1ExperimentalParticipants will use a continuous blood glucose monitoring and visualization of CVDs risk.
Receives: Device: CGM; Diagnostic Test: Visualization
Intervention group 2ExperimentalParticipants will use a continuous blood glucose monitoring.
Receives: Device: CGM
Intervention group 3ExperimentalParticipants will use a visualization of CVDs risk.
Receives: Diagnostic Test: Visualization
Control groupNo interventionNo intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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.

  2. 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.

    Measured: 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.

  3. 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.

    Measured: 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 (1)

  1. 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2024
  2. Study start6 May 2024
  3. Primary completion6 Dec 2024
  4. Study completion6 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06226948
Sponsor's protocol ID
05a/2I-2023
Status last verified
Jan 2025
First submitted
17 Jan 2024
Last updated
24 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The anonymity of all research participants will be guaranteed throughout the research. Only the researcher involved will have access to the anonymised data.

Publications

  • 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.

    PubMed 25253039

  • Svensek A, Lorber M, Klemenc-Ketis Z, Gosak L, Mursec D, Stiglic G. Interactive Digital Visualization Counseling for Lifestyle Change in Patients at Risk of Cardiovascular Diseases: Randomized Controlled Trial. JMIR Public Health Surveill. 2026 Jan 22;12:e83488. doi: 10.2196/83488.

    PubMed 41569629

Questions about this trial

What is this clinical trial studying?

A study testing CGM and Visualization in people with Cardiovascular Diseases and Coronary Artery Disease, run by University Maribor at 1 site in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06226948, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.

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