Ireland
--:--IST
Starting soon Observational

DELphi Procedure for Developing Recommendations for the Implementation of Wearable Devices and Polygenic Risk Scores

NCT07358481 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2026-02
Last updated
2026-01-23

Condition(s) studied

Wearable Electronic DevicesPolygenic Risk ScoreCVD - Cardiovascular DiseasePrimary Prevention

Study summary

DEL-DIP is a prospective observational study employing a Delphi methodology (at least two online rounds) to elicit and consolidate the views of an expert panel within the INNOPREV project. The study aims to develop operational recommendations to support the coordinated implementation of Polygenic Risk Scores (PRS) and wearable devices in cardiovascular prevention. Specifically, it addresses the following research question: which recommendations and requirements-genomic, digital, and clinical/organizational-are necessary to integrate PRS and wearable technologies into routine practice and healthcare services, and for which of these elements do experts achieve consensus (defined as a Content Validity Index, CVI, \> 79%)

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
Accepted
Inclusion criteria * Experts in cardiology * Experts in personalized medicine * Experts in digital health. Exclusion criteria \- Failure to provide informed consent (i.e., non-acceptance of the informed consent form)

Primary outcome measure(s)

  • Achievement of expert-panel consensus on recommendations for the implementation of PRS and wearable devices, as assessed by the Content Validity Index (CVI) — At the end of the Delphi process (up to 4 months)
    Achievement of consensus among the expert panel on the proposed recommendations. Consensus will be defined, for each item, as a Content Validity Index (CVI) \> 79%, where the CVI represents the proportion of experts assigning a rating of 4 or 5

Trial sites (1)

FacilityCityRegionStatus
Policlinico Universitario Fondazione Agostino Gemelli IRCCS Roma RM
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07358481 on ClinicalTrials.gov ↗ ← All trials in Italy