UIZ.CARE Pilot Study – 2025

Why this pilot matters

General Practitioners (GPs) in the Netherlands face unprecedented strain. Up to 40% of consultations involve mental health concerns, yet GPs are overwhelmed by administrative tasks and fragmented digital workflows. This often leads to delayed recognition of distress, unnecessary referrals to GGZ services, and poorer outcomes for young people—especially Gen Z, who are reporting record levels of stress, anxiety, and sleep problems.

UIZ.CARE was designed to repair this broken link. Our AI-enabled platform streamlines GP administration, integrates self-reported and wearable data, and highlights early risk patterns in non-stigmatizing language. The goal: free up GP time, empower earlier detection, and strengthen the primary care pathway.

The Pilot Study

Duration: 14 weeks (2-week baseline, 12-week intervention)
Participants: 25 GPs (≥6 sessions/week) and 100–200 Gen Z patients (18+, non-chronic conditions, smartphone access).
Design: Before–after feasibility pilot, run under MDR Class IIa, GDPR, and ISO/NEN aligned controls.

What We’re Testing (4 Key Claims)

  1. Efficiency (Admin Workload Reduction)
    – Target: cut GP admin time by 30–40% (≈8–10 hours per week).
    – Tools: time diaries, EHR/portal logs, GP surveys.

  2. Risk & Safety (MDR Class IIa Readiness)
    – Safe operation with 0 serious adverse device events (SADEs).
    – QMS and CE-readiness checklist completed with no critical gaps.

  3. Data Interoperability & AI
    – Successful ingestion of wearable data (Fitbit, Google Fit) with ≥90% completeness.
    – Median latency <3 seconds.
    – GP rating of usefulness for triage support.

  4. User Experience (Usability & Engagement)
    – System Usability Scale (SUS) score ≥75.
    – ≥80% task success rate for both GPs and patients.

Why the Sample Size Is Enough

Although this pilot is not powered for clinical outcomes, the design is fit-for-purpose for feasibility:

  • 25 GPs provide paired, within-subject comparisons with >80% power to detect the expected efficiency gains.

  • 100–200 patients allow precise estimates of usability, interoperability, and safety:

    • SUS confidence intervals within ±2–3 points.

    • Ingestion rates estimated with ±5–6% precision.

    • Safety monitoring strong enough to rule out SADEs at <3% incidence.

This represents ~4% of our rollout target (638 GPs, 300k Gen Z) and offers an information-rich, operationally diverse sample before scaling.

Safeguards in Place

  • Privacy & Security: GDPR-compliant, encrypted storage, role-based access, account deletion.

  • Consent: Clear, separate consent forms for GPs and patients with withdrawal options.

  • Oversight: Bi-weekly steering group, weekly safety checks, 24h escalation for critical events.

  • Stop/hold rules: Any SADE, data breach, or repeated ingestion outage pauses the study until resolved.

What Happens Next

By study close, UIZ.CARE will deliver:

  • An integrated evaluation report (efficiency, UX, interoperability, safety).

  • An updated Safety Risk File.

  • A Usability Engineering Report.

  • A full Data Protection Impact Assessment (DPIA).

  • A CE-readiness checklist mapping pilot results to MDR technical documentation.

These outputs will directly support our regulatory pathway and market entry in the Netherlands and Germany, with larger trials to follow.

👉 Want to learn more or join the pilot?
Fill in the expression-of-interest form. Together, we can give GPs back their time and ensure that young people get the right support at the right moment.