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

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 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.

Conditions

• Cardiovascular Risk Factors
• Insulin Resistance
• Obesity
• Dyslipidemias
• Metabolic Syndrome

Interventions

BEHAVIORAL

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 (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.

DIAGNOSTIC_TEST

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, 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.

Sponsors & Collaborators

• Nemocnice AGEL Trinec-Podlesi a.s.

  lead OTHER

Principal Investigators

• Bogna Jiravska Godula, MD, PhD, MBA · Nemocnice AGEL Trinec-Podlesi a.s.

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-04-01

Primary Completion

2028-12-31

Completion

2028-12-31

Countries

• Czechia

Study Locations