Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EK 69/25 | Other Identifier | Ethics Committee, Nemocnice AGEL Trinec-Podlesi |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STELA Digital Preventive Medicine Platform | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | 12 months (T+12) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (T0) to 12 months (T+12) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lifestyle Behavior Scores | Quantification of improvement in self-reported physical activity, sleep quality, and psychosocial stress scores from online questionnaires administered at baseline, 1 month, 6 months, and 12 months. | Baseline (T0) to 12 months (T+12) |
| Scalability Assessment |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bogna Jiravska Godula, MD, PhD, MBA | Nemocnice AGEL Trinec-Podlesi a.s. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Preventive Medicine, Nemocnice AGEL Trinec-Podlesi a.s. | Třinec | Moravian-Silesian Region | 73961 | Czechia |
Anonymized dataset of at least 100 complete participant records (T0-T12) will be shared for academic research purposes after study completion and primary publication.
Starting approximately 6 months after primary publication (estimated 2029) and available indefinitely.
Available under CC BY-NC 4.0 license for academic use. Requests submitted to the Center for Preventive Medicine, Nemocnice AGEL Trinec-Podlesi.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Comprehensive Preventive Health Assessment | Diagnostic 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. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Study completion (36 months) |
Pilot implementation of the STELA platform in one additional AGEL network facility, evaluating transferability of processes, quality indicators, and capacity requirements. |
| Through study completion (up to 36 months) |
| Open Validation Dataset | Creation of an anonymized dataset of at least 100 complete participant records (T0 through T+12) for future AI-driven development of AGI weighting algorithms, to be released under CC BY-NC 4.0 license. | Study completion (36 months) |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D009765 | Obesity |
| D050171 | Dyslipidemias |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D052439 | Lipid Metabolism Disorders |
Not provided
Not provided