Using the Visualization for Lifestyle Change in Patients At Risk of Cardiovascular Diseases
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cardiovascular-diseases
Started May 2024
Shorter than P25 for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2024
CompletedFirst Posted
Study publicly available on registry
January 26, 2024
CompletedStudy Start
First participant enrolled
May 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 6, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 6, 2024
CompletedJanuary 24, 2025
January 1, 2025
7 months
January 17, 2024
January 21, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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.
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.
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 Outcomes (1)
Assessment in Biological age
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.
Study Arms (4)
Intervention group 1
EXPERIMENTALParticipants will use a continuous blood glucose monitoring and visualization of CVDs risk.
Intervention group 2
EXPERIMENTALParticipants will use a continuous blood glucose monitoring.
Intervention group 3
EXPERIMENTALParticipants will use a visualization of CVDs risk.
Control group
NO INTERVENTIONNo intervention.
Interventions
Participants will wear CGM monitors for 10 days.
Enriched visualization of SCORE2 CVD risk.
Eligibility Criteria
You may qualify if:
- individuals ages more than 40 years
- without serious disease progression
- at least one risk factor for CVDs
You may not qualify if:
- individuals younger than 40 years
- with serious disease progression
- without risk factor for CVDs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Health Sciences
Maribor, Slovenia
Related 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.
PMID: 25253039BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 17, 2024
First Posted
January 26, 2024
Study Start
May 6, 2024
Primary Completion
December 6, 2024
Study Completion
December 6, 2024
Last Updated
January 24, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share
The anonymity of all research participants will be guaranteed throughout the research. Only the researcher involved will have access to the anonymised data.