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

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Pilot implementation of the STELA platform in one additional AGEL network facility, evaluating transferability of processes, quality indicators, and capacity requirements.

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.