Cardiovascular Risk FactorsCPM-STELANCT07551960
Pilot Validation of the STELA Preventive Medicine Platform to Reduce Modifiable Health Risk Factors in Adults (CPM-STELA)
A study testing STELA Digital Preventive Medicine Platform and Comprehensive Preventive Health Assessment in people with Cardiovascular Risk Factors and Insulin Resistance, run by Nemocnice AGEL Trinec-Podlesi a.s. at 1 site in Czechia.
Trial summary
This study evaluates a comprehensive digital health platform called STELA, developed at the Center for Preventive Medicine (CPM) of AGEL Hospital Trinec-Podlesi in Czechia. The STELA system is designed to identify, quantify, and reduce modifiable health risk factors in adults who have no established cardiovascular… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factors, Insulin Resistance, Obesity
- What is being tested?
- STELA Digital Preventive Medicine Platform and Comprehensive Preventive Health Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Apr 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 80 years
- Indicated for primary cardiovascular prevention (no established cardiovascular, cerebrovascular, or other disease requiring secondary prevention)
- Able and willing to complete the full study assessment protocol
- Registered via online CPM portal or referred through AGEL network
- Willing and able to provide written informed consent
Who cannot join
- Established cardiovascular, cerebrovascular, or peripheral vascular disease requiring secondary prevention
- Pregnancy or breastfeeding
- Severe psychiatric disorder
- Active oncological disease
- Any acute or decompensated illness
- Inability to complete the study assessment protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site
Center for Preventive Medicine, Nemocnice AGEL Trinec-Podlesi a.s.
Třinec, Moravian-Silesian Region, 73961
About this study
Official title: Design, Development and Pilot Validation of an Interventional System of the STELA Center for Preventive Medicine to Reduce Modifiable Health Risk Factors in the Adult Population (CPM-STELA)
This study evaluates a comprehensive digital health platform called STELA, developed at the Center for Preventive Medicine (CPM) of AGEL Hospital Trinec-Podlesi in Czechia. The STELA system is designed to identify, quantify, and reduce modifiable health risk factors in adults who have no established cardiovascular disease.
Each participant undergoes a thorough baseline assessment including questionnaires (lifestyle, psychosocial, medical history), physical and functional tests (blood pressure, body composition via InBody, hand grip strength, cardiopulmonary exercise testing/VO2max, Functional Movement Screen), laboratory panel (lipid profile, ApoB, Lp(a), insulin resistance/HOMA-IR, hs-CRP, vitamin D3, uric acid), and imaging studies (coronary artery calcium score by CT in participants over 30 years, echocardiography, abdominal ultrasound, limited polysomnography).
Read more
All data are entered into the STELA platform, which calculates a composite AGEL Gamification Index (AGI, scored 0-100%) with visual feedback via spider and funnel charts. Based on the AGI results, a 45-minute physician consultation using shared decision-making generates a personalized prevention plan.
The intervention includes: interactive e-learning modules (nutrition, physical activity, sleep, stress management), coordinated referrals to physiotherapy, nutritional counseling, addiction services, and optional health coaching/hypnosis, automated digital reminders, a motivational telephone call at 1 month, and a follow-up clinical visit at 6 months with repeat laboratory and functional testing. A final comprehensive reassessment identical to baseline occurs at 12 months.
The primary objective is to demonstrate that the STELA-guided intervention improves the overall AGI score at 12 months compared to baseline, and to confirm feasibility and acceptability of the protocol. Secondary objectives include improvement in individual risk biomarkers (insulin resistance/HOMA-IR, body composition, VO2max, muscle strength, vitamin D), participant adherence of at least 80%, patient satisfaction of at least 80%, and reduction of clinician administrative time by at least 50%.
This is a single-arm pilot study enrolling at least 100 participants to establish feasibility, acceptability, and preliminary efficacy of the STELA system before a future multicenter randomized trial.
Read the detailed description
BACKGROUND: Non-communicable chronic diseases, particularly cardiovascular, metabolic, and neurodegenerative conditions, represent the leading cause of morbidity and mortality in Czechia and globally. Up to 80% of premature cardiovascular deaths are preventable through lifestyle modification and early treatment of risk factors (WHO, ESC 2021 Prevention Guidelines, AHA Life's Essential 8). Traditional primary prevention relies on isolated assessments and risk calculators (SCORE2, ASCVD) that do not incorporate key metabolic health parameters, body composition, or psychosocial motivational factors. Digital solutions with gamification have been shown to improve adherence and reduce administrative burden, but available commercial applications are not integrated into hospital workflows and lack comprehensive clinical validation.
STELA CONCEPT: The STELA system employs a task-shifting model: university-educated non-physician healthcare professionals, working under the supervision of an internist specializing in preventive medicine, conduct standardized evaluations of 25 parameters across three domains (clinical, lifestyle, psychosocial). An algorithm converts these data into the AGEL Gamification Index (AGI), providing an intuitive 0-100% score with immediate spider/funnel chart visualization. The AGI has undergone internal validation in over 70 examinations since August 2024, demonstrating 60-70% administrative time savings and over 90% patient satisfaction (STELA 2025 poster presentation). Formal validation of the AGI against individual biomarkers is a key aspect of this study.
STUDY DESIGN: Single-arm prospective interventional pilot study with pre-post assessment at a single center (CPM, AGEL Hospital Trinec-Podlesi, Czechia), 2026-2028.
ASSESSMENT SCHEDULE: T0 (Baseline): Full protocol including questionnaires, physical/functional tests, laboratory panel, imaging, AGI calculation, 45-min physician consultation, personalized plan. T+1 month: Online questionnaire reporting, motivational telephone call. T+6 months: Repeat selected laboratory and functional parameters (HOMA-IR, body composition, muscle strength, vitamin D), AGI recalculation, plan revision. T+12 months: Full reassessment identical to T0 (except CT calcium score not repeated).
INTERVENTION COMPONENTS: (1) Interactive multimedia e-learning covering nutrition, physical activity, sleep hygiene, and stress management. (2) Coordinated multidisciplinary referrals to physiotherapy, nutritional counseling, addiction services, and optional hypnosis/health coaching. (3) Automated digital reminders and telemedicine support. (4) Motivational telephone contacts at T+1 and T+6 months. (5) Real-time AGI tracking with automated comparison reports via STELA platform.
STATISTICAL ANALYSIS: Primary outcome (AGI change) analyzed by paired t-test or Wilcoxon signed-rank test. Secondary biomarker outcomes analyzed using paired comparisons, generalized estimating equations (GEE) and linear mixed-effects models. Statistical significance set at alpha = 0.05. Analysis performed in IBM SPSS Statistics version 29.
DATA MANAGEMENT: Clinical data encrypted (AES-GCM-256) on a local AGEL server with role-based access control. GDPR-compliant data export available to participants. Quarterly internal quality audits targeting less than 2% data entry error rate.
- Conditions
- Cardiovascular Risk Factors, Insulin Resistance, Obesity, Dyslipidemias, Metabolic Syndrome
- Being tested
- STELA Digital Preventive Medicine Platform, Comprehensive Preventive Health Assessment
- Keywords
- primary prevention, preventive cardiology, digital health, gamification, lifestyle intervention, body composition, cardiopulmonary fitness, HOMA-IR, coronary artery calcium score, telemedicine
- Medical subject headings
- Insulin Resistance, Obesity, Dyslipidemias, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STELA Digital Preventive Medicine PlatformBehavioural
Comprehensive digital health platform integrating standardized assessment of 25 clinical, lifestyle, and psychosocial parameters into the AGEL Gamification Index (AGI, 0-100%). Intervention includes: (1) personalized lifestyle recommendations generated algorithmically by the STELA platform based on individual risk profiles; (2) interactive multimedia e-learning modules covering nutrition, physical activity, sleep hygiene, and stress management; (3) coordinated multidisciplinary referrals (physiotherapy, nutritional counseling, addiction services, optional health coaching); (4) automated digital reminders and telemedicine support; (5) motivational telephone contacts at 1 and 6 months post-enrollment; (6) real-time AGI tracking with visual feedback (spider and funnel charts) and automated comparison reports.
Comprehensive Preventive Health AssessmentDiagnostic test
Standardized multi-domain assessment protocol performed at baseline (T0) and 12 months (T+12), with selected parameters repeated at 6 months (T+6). Includes: (a) electronic questionnaires (lifestyle, psychosocial, medical history); (b) physical/functional tests: blood pressure, waist circumference, body composition (InBody bioimpedance), hand grip dynamometry, cardiopulmonary exercise test (VO2max by spiroergometry), Functional Movement Screen (FMS); (c) laboratory panel: lipid profile, apolipoprotein B, lipoprotein(a), HOMA-IR, high-sensitivity CRP, 25-OH vitamin D3, uric acid; (d) imaging: coronary artery calcium score (CT, participants over 30 years), transthoracic echocardiography, abdominal ultrasound, limited polysomnography.
| Study group | Role | What they receive |
|---|---|---|
| STELA Intervention | Experimental | All enrolled participants receive the full STELA preventive medicine intervention including comprehensive baseline assessment, personalized prevention plan based on AGI score, multimedia e-learning, multidisciplinary referrals, telemedicine support, and motivational contacts, with reassessment at 6 and 12 months. Receives: Behavioral: STELA Digital Preventive Medicine Platform; Diagnostic Test: Comprehensive Preventive Health Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in AGEL Gamification Index (AGI) from Baseline to 12 Months
Change in the composite AGEL Gamification Index (AGI), a platform-calculated score ranging from 0 to 100% that integrates 25 clinical, lifestyle, and psychosocial parameters. The AGI is computed algorithmically by the STELA platform based on standardized assessment data. Higher scores indicate better overall health risk profile. The target is a mean improvement of at least 5 percentage points at the cohort level.
Measured: Baseline (T0) to 12 months (T+12)
Protocol Feasibility and Participant Acceptability
Proportion of enrolled participants who complete the full intervention program (all scheduled visits and assessments from T0 through T+12). Target: at least 80% complete protocol adherence. Additionally, participant satisfaction measured by a 5-point Likert scale questionnaire (target: at least 80% scoring 4 or 5 out of 5).
Measured: 12 months (T+12)
Secondary outcomes (9)
Change in Insulin Resistance (HOMA-IR) from Baseline to 12 Months
Change in the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), calculated from fasting glucose and fasting insulin concentrations. HOMA-IR is a validated, widely used surrogate marker of insulin resistance. Assessed as a continuous variable with paired pre-post comparison.
Measured: Baseline (T0) to 12 months (T+12)
Change in Body Composition from Baseline to 12 Months
Description:
Change in visceral fat area measured by multi-frequency 8-point tactile electrode bioelectrical impedance analysis (InBody device) performed in the morning in a fasting state using a standardized protocol. Assessed as a continuous variable with paired pre-post comparison. Additional body composition parameters (body fat percentage by the same device; waist circumference in cm measured by non-elastic tape at the midpoint between iliac crest and lowest rib) will be reassessed at the same visits and reported as supplementary analyses in the accompanying publication.
Measured: Baseline (T0) to 12 months (T+12)
Change in Cardiorespiratory Fitness (VO2max) from Baseline to 12 Months
Change in maximal oxygen consumption (VO2max, mL/kg/min) measured by cardiopulmonary exercise testing (spiroergometry). Assessed as a continuous variable with paired pre-post comparison.
Measured: Baseline (T0) to 12 months (T+12)
Change in Muscle Strength from Baseline to 12 Months
Change in hand grip strength (kg) measured by calibrated hand dynamometer. Assessed as a continuous variable with paired pre-post comparison. Hand grip strength is a validated marker of overall muscle function and predictor of cardiometabolic risk.
Measured: Baseline (T0) to 12 months (T+12)
Change in Vitamin D Status from Baseline to 12 Months
Change in serum 25-hydroxyvitamin D3 (25-OH vitamin D3, nmol/L). Assessed as a continuous variable with paired pre-post comparison. Vitamin D deficiency is a modifiable risk factor associated with cardiovascular and metabolic disease.
Measured: Baseline (T0) to 12 months (T+12)
Change in AGI and Biomarkers at 6-Month Interim Assessment
Description:
Change in the composite AGEL Gamification Index (AGI), a platform-calculated score ranging from 0 to 100% that integrates 25 clinical, lifestyle, and psychosocial parameters, assessed at the 6-month interim reassessment. The AGI is computed algorithmically by the STELA platform based on standardized assessment data. The interim assessment provides an early signal of intervention effect. Biomarkers reassessed at the same visit (HOMA-IR, body composition, muscle strength, vitamin D) are captured in the respective 12-month Outcome Measures and will also be reported as 6-month supplementary analyses in the accompanying publication.
Measured: Baseline (T0) to 6 months (T+6)
Reduction in Clinician Administrative Time
Average physician administrative time (in minutes) required to generate the patient summary report, compared to the pre-STELA manual reporting workflow. Measured by time-motion analysis. Target: at least 50% reduction.
Measured: Baseline process (pre-study) compared to study process at 12 months
Digital Platform Reliability
Description:
Percentage of erroneous data entries detected during quarterly internal quality audits of two newly deployed STELA software modules (intervention module and reporting module). An erroneous entry is defined as a data field that fails automated validation rules or is inconsistent with source documentation verified by manual review. Target error rate is below 2% across all audited records. Reliability is also confirmed by successful deployment and continuous operation of both modules throughout the study period.
Measured: Through study completion (up to 36 months)
Cost-Benefit Analysis
Description:
Direct monetary cost per enrolled participant compiled across the full 12-month intervention program, including personnel time, laboratory tests, imaging, intervention materials, and platform-related expenses. Cost is reported in Euros per participant. Estimated physician time savings attributable to platform automation and the resulting economic sustainability report will be provided as supplementary analyses to support future reimbursement negotiations with health insurance companies.
Measured: Study completion (36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start1 Apr 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nemocnice AGEL Trinec-Podlesi a.s.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Otakar Jiravsky, Nemocnice AGEL Trinec-Podlesi a.s.
- Investigators
- Bogna Jiravska Godula, MD, PhD, MBA, Principal investigator, Nemocnice AGEL Trinec-Podlesi a.s.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551960
- Sponsor's protocol ID
- INT2025004
- Other IDs
- EK 69/25
- Acronym
- CPM-STELA
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized dataset of at least 100 complete participant records (T0-T12) will be shared for academic research purposes after study completion and primary publication.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design, Development and Pilot Validation of an Interventional System of the STELA Center for Preventive Medicine to Reduce Modifiable Health Risk Factors in the Adult Population (CPM-STELA)
- ClinicalTrials.gov ID
- NCT07551960
- Acronym / sponsor ID
- CPM-STELA / INT2025004
- Conditions
- Cardiovascular Risk Factors, Insulin Resistance, Obesity, Dyslipidemias, Metabolic Syndrome
- Keywords
- primary prevention, preventive cardiology, digital health, gamification, lifestyle intervention, body composition, cardiopulmonary fitness, HOMA-IR
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nemocnice AGEL Trinec-Podlesi a.s.University, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates a comprehensive digital health platform called STELA, developed at the Center for Preventive Medicine (CPM) of AGEL Hospital Trinec-Podlesi in Czechia. The STELA system is designed to identify, quantify, and reduce modifiable health risk factors in adults who have no established cardiovascular disease.
Each participant undergoes a thorough baseline assessment including questionnaires (lifestyle, psychosocial, medical history), physical and functional tests (blood pressure, body composition via InBody, hand grip strength, cardiopulmonary exercise testing/VO2max, Functional Movement Screen), laboratory panel (lipid profile, ApoB, Lp(a), insulin resistance/HOMA-IR, hs-CRP, vitamin D3, uric acid), and imaging studies (coronary artery calcium score by CT in participants over 30 years, echocardiography, abdominal ultrasound, limited polysomnography).
All data are entered into the STELA platform, which calculates a composite AGEL Gamification Index (AGI, scored 0-100%) with visual feedback via spider and funnel charts. Based on the AGI results, a 45-minute physician consultation using shared decision-making generates a personalized prevention plan.
The intervention includes: interactive e-learning modules (nutrition, physical activity, sleep, stress management), coordinated referrals to physiotherapy, nutritional counseling, addiction services, and optional health coaching/hypnosis, automated digital reminders, a motivational telephone call at 1 month, and a follow-up clinical visit at 6 months with repeat laboratory and functional testing. A final comprehensive reassessment identical to baseline occurs at 12 months.
The primary objective is to demonstrate that the STELA-guided intervention improves the overall AGI score at 12 months compared to baseline, and to confirm feasibility and acceptability of the protocol. Secondary objectives include improvement in individual risk biomarkers (insulin resistance/HOMA-IR, body composition, VO2max, muscle strength, vitamin D), participant adherence of at least 80%, patient satisfaction of at least 80%, and reduction of clinician administrative time by at least 50%.
This is a single-arm pilot study enrolling at least 100 participants to establish feasibility, acceptability, and preliminary efficacy of the STELA system before a future multicenter randomized trial.
Detailed description
BACKGROUND: Non-communicable chronic diseases, particularly cardiovascular, metabolic, and neurodegenerative conditions, represent the leading cause of morbidity and mortality in Czechia and globally. Up to 80% of premature cardiovascular deaths are preventable through lifestyle modification and early treatment of risk factors (WHO, ESC 2021 Prevention Guidelines, AHA Life's Essential 8). Traditional primary prevention relies on isolated assessments and risk calculators (SCORE2, ASCVD) that do not incorporate key metabolic health parameters, body composition, or psychosocial motivational factors. Digital solutions with gamification have been shown to improve adherence and reduce administrative burden, but available commercial applications are not integrated into hospital workflows and lack comprehensive clinical validation.
STELA CONCEPT: The STELA system employs a task-shifting model: university-educated non-physician healthcare professionals, working under the supervision of an internist specializing in preventive medicine, conduct standardized evaluations of 25 parameters across three domains (clinical, lifestyle, psychosocial). An algorithm converts these data into the AGEL Gamification Index (AGI), providing an intuitive 0-100% score with immediate spider/funnel chart visualization. The AGI has undergone internal validation in over 70 examinations since August 2024, demonstrating 60-70% administrative time savings and over 90% patient satisfaction (STELA 2025 poster presentation). Formal validation of the AGI against individual biomarkers is a key aspect of this study.
STUDY DESIGN: Single-arm prospective interventional pilot study with pre-post assessment at a single center (CPM, AGEL Hospital Trinec-Podlesi, Czechia), 2026-2028.
ASSESSMENT SCHEDULE: T0 (Baseline): Full protocol including questionnaires, physical/functional tests, laboratory panel, imaging, AGI calculation, 45-min physician consultation, personalized plan. T+1 month: Online questionnaire reporting, motivational telephone call. T+6 months: Repeat selected laboratory and functional parameters (HOMA-IR, body composition, muscle strength, vitamin D), AGI recalculation, plan revision. T+12 months: Full reassessment identical to T0 (except CT calcium score not repeated).
INTERVENTION COMPONENTS: (1) Interactive multimedia e-learning covering nutrition, physical activity, sleep hygiene, and stress management. (2) Coordinated multidisciplinary referrals to physiotherapy, nutritional counseling, addiction services, and optional hypnosis/health coaching. (3) Automated digital reminders and telemedicine support. (4) Motivational telephone contacts at T+1 and T+6 months. (5) Real-time AGI tracking with automated comparison reports via STELA platform.
STATISTICAL ANALYSIS: Primary outcome (AGI change) analyzed by paired t-test or Wilcoxon signed-rank test. Secondary biomarker outcomes analyzed using paired comparisons, generalized estimating equations (GEE) and linear mixed-effects models. Statistical significance set at alpha = 0.05. Analysis performed in IBM SPSS Statistics version 29.
DATA MANAGEMENT: Clinical data encrypted (AES-GCM-256) on a local AGEL server with role-based access control. GDPR-compliant data export available to participants. Quarterly internal quality audits targeting less than 2% data entry error rate.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STELA Intervention | Experimental | Behavioral: STELA Digital Preventive Medicine Platform, Diagnostic Test: Comprehensive Preventive Health AssessmentAll enrolled participants receive the full STELA preventive medicine intervention including comprehensive baseline assessment, personalized prevention plan based on AGI score, multimedia e-learning, multidisciplinary referrals, telemedicine support, and motivational contacts, with reassessment at 6 and 12 months. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 80 years
- Indicated for primary cardiovascular prevention (no established cardiovascular, cerebrovascular, or other disease requiring secondary prevention)
- Able and willing to complete the full study assessment protocol
- Registered via online CPM portal or referred through AGEL network
- Willing and able to provide written informed consent
Key exclusion criteria (6 listed)
- Established cardiovascular, cerebrovascular, or peripheral vascular disease requiring secondary prevention
- Pregnancy or breastfeeding
- Severe psychiatric disorder
- Active oncological disease
- Any acute or decompensated illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STELA Digital Preventive Medicine PlatformComprehensive digital health platform integrating standardized assessment of 25 clinical, lifestyle, and psychosocial parameters into the AGEL Gamification Index (AGI, 0-100%). Intervention includes: (1) personalized lifestyle recommendations generated algorithmically by the STELA platform based on individual risk profiles; (2) interactive multimedia e-learning modules covering nutrition, physical activity, sleep hygiene, and stress management; (3) coordinated multidisciplinary referrals (physiotherapy, nutritional counseling, addiction services, optional health coaching); (4) automated digital reminders and telemedicine support; (5) motivational telephone contacts at 1 and 6 months post-enrollment; (6) real-time AGI tracking with visual feedback (spider and funnel charts) and automated comparison reports. | Behavioural | STELA Intervention |
| Comprehensive Preventive Health AssessmentStandardized multi-domain assessment protocol performed at baseline (T0) and 12 months (T+12), with selected parameters repeated at 6 months (T+6). Includes: (a) electronic questionnaires (lifestyle, psychosocial, medical history); (b) physical/functional tests: blood pressure, waist circumference, body composition (InBody bioimpedance), hand grip dynamometry, cardiopulmonary exercise test (VO2max by spiroergometry), Functional Movement Screen (FMS); (c) laboratory panel: lipid profile, apolipoprotein B, lipoprotein(a), HOMA-IR, high-sensitivity CRP, 25-OH vitamin D3, uric acid; (d) imaging: coronary artery calcium score (CT, participants over 30 years), transthoracic echocardiography, abdominal ultrasound, limited polysomnography. | Diagnostic test | STELA Intervention |
Primary outcome
Change in AGEL Gamification Index (AGI) from Baseline to 12 Months
Time frame: Baseline (T0) to 12 months (T+12)
Change in the composite AGEL Gamification Index (AGI), a platform-calculated score ranging from 0 to 100% that integrates 25 clinical, lifestyle, and psychosocial parameters. The AGI is computed algorithmically by the STELA platform based on standardized assessment data. Higher scores indicate better overall health risk profile. The target is a mean improvement of at least 5 percentage points at the cohort level.
Protocol Feasibility and Participant Acceptability
Time frame: 12 months (T+12)
Proportion of enrolled participants who complete the full intervention program (all scheduled visits and assessments from T0 through T+12). Target: at least 80% complete protocol adherence. Additionally, participant satisfaction measured by a 5-point Likert scale questionnaire (target: at least 80% scoring 4 or 5 out of 5).
9 secondary outcomes
Change in Insulin Resistance (HOMA-IR) from Baseline to 12 Months
Time frame: Baseline (T0) to 12 months (T+12)
Change in Body Composition from Baseline to 12 Months
Time frame: Baseline (T0) to 12 months (T+12)
Change in Cardiorespiratory Fitness (VO2max) from Baseline to 12 Months
Time frame: Baseline (T0) to 12 months (T+12)
Change in Muscle Strength from Baseline to 12 Months
Time frame: Baseline (T0) to 12 months (T+12)
Change in Vitamin D Status from Baseline to 12 Months
Time frame: Baseline (T0) to 12 months (T+12)
Change in AGI and Biomarkers at 6-Month Interim Assessment
Time frame: Baseline (T0) to 6 months (T+6)
Reduction in Clinician Administrative Time
Time frame: Baseline process (pre-study) compared to study process at 12 months
Digital Platform Reliability
Time frame: Through study completion (up to 36 months)
Cost-Benefit Analysis
Time frame: Study completion (36 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: Yes. Anonymized dataset of at least 100 complete participant records (T0-T12) will be shared for academic research purposes after study completion and primary publication.
Related trials for Cardiovascular Risk Factors
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Not yet recruiting
Multimodal AI-Driven Out-of-Hospital Management for Hypertension and Cardiometabolic Risk
Hypertension, Hyperglycemia
Recruiting
Determining Efficacy of an Artificial Intelligence-based System for Heart Failure Detection Through Interpretation of Electrocardiograms (DECISION)
Heart Failure, Cardiovascular Risk Factors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bogna Jiravska Godula, MD, PhD, MBA principal investigator
Nemocnice AGEL Trinec-Podlesi a.s.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STELA Digital Preventive Medicine Platform and Comprehensive Preventive Health Assessment in people with Cardiovascular Risk Factors and Insulin Resistance, run by Nemocnice AGEL Trinec-Podlesi a.s. at 1 site in Czechia.
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 5 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 27 Apr 2026. 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 Czechia. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in AGEL Gamification Index (AGI) from Baseline to 12 Months (time frame: Baseline (T0) to 12 months (T+12)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2026.