A digital prevention program to lower health risks in adults without heart disease
Tests a digital prevention platform in adults without cardiovascular disease.
Plain-language title generated from the registry record
Registry title: Pilot Validation of the STELA Preventive Medicine Platform to Reduce Modifiable Health Risk Factors in Adults (CPM-STELA)
Key facts
- Where
- Třinec, CzechiaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 80 who have no established heart or blood vessel disease and are being considered for primary cardiovascular prevention. It tests the STELA digital platform.
- Age
- 18 to 80 years
- Sex
- All sexes can join.
- Disease stage
- Primary cardiovascular prevention: no established cardiovascular, cerebrovascular, or other disease that needs secondary prevention.
Main reasons for not taking part
- Established cardiovascular, cerebrovascular, or peripheral vascular disease needing secondary prevention
- Pregnancy or breastfeeding
- Severe psychiatric disorder
- Active cancer
- Any acute or decompensated illness
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07551960, who can take part
Where in Czechia
- Center for Preventive Medicine, Nemocnice AGEL Trinec-Podlesi a.s.Třinec, CzechiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Nemocnice AGEL Trinec-Podlesi a.s.
- Trial code
- NCT07551960
- Record updated
- 27 April 2026
- Original description
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.Read full original descriptionShow less
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).
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.
Inclusion: 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.
Exclusion: Established cardiovascular, cerebrovascular, or peripheral vascular disease requiring secondary prevention; Severe psychiatric disorder; Active oncological disease; Any acute or decompensated illness; Pregnancy or breastfeeding; Inability to complete the study assessment protocol.