Pilot Validation of the STELA Preventive Medicine Platform to Reduce Modifiable Health Risk Factors in Adults (CPM-STELA)

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое STELA Digital Preventive Medicine Platform
  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 (physio
• Диагностический тест Comprehensive Preventive Health Assessment
  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, apolipop

Первичные конечные точки

• Change in AGEL Gamification Index (AGI) from Baseline to 12 Months [Срок оценки: Baseline (T0) to 12 months (T+12)]
• Protocol Feasibility and Participant Acceptability [Срок оценки: 12 months (T+12)]

Вторичные конечные точки (9)

• Change in Insulin Resistance (HOMA-IR) from Baseline to 12 Months [Срок оценки: Baseline (T0) to 12 months (T+12)]
• Change in Body Composition from Baseline to 12 Months [Срок оценки: Baseline (T0) to 12 months (T+12)]
• Change in Cardiorespiratory Fitness (VO2max) from Baseline to 12 Months [Срок оценки: Baseline (T0) to 12 months (T+12)]
• Change in Muscle Strength from Baseline to 12 Months [Срок оценки: Baseline (T0) to 12 months (T+12)]
• Change in Vitamin D Status from Baseline to 12 Months [Срок оценки: Baseline (T0) to 12 months (T+12)]
• Change in AGI and Biomarkers at 6-Month Interim Assessment [Срок оценки: Baseline (T0) to 6 months (T+6)]
• Reduction in Clinician Administrative Time [Срок оценки: Baseline process (pre-study) compared to study process at 12 months]
• Digital Platform Reliability [Срок оценки: Through study completion (up to 36 months)]
• Cost-Benefit Analysis [Срок оценки: Study completion (36 months)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Чехия · 1 центр

• Center for Preventive Medicine, Nemocnice AGEL Trinec-Podlesi a.s. — Třinec

Идентификаторы

NCT: NCT07551960 · INT2025004 · EK 69/25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗