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

NCT07358481 | Not Yet Recruiting

• 1 other identifier: 8217
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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%)

Conditions

Wearable Electronic Devices; Polygenic Risk Score; CVD - Cardiovascular Disease; Primary Prevention

Keywords

cardiovascular prevention

Outcome Measures

Primary Outcomes (1)

• Achievement of expert-panel consensus on recommendations for the implementation of PRS and wearable devices, as assessed by the Content Validity Index (CVI)

  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

  At the end of the Delphi process (up to 4 months)

Secondary Outcomes (3)

• Identification of recommendations with partial agreement (CVI 70-79%)

  After each Delphi round, through completion of the process (up to 4 months)

• Development of the final set of recommendations, structured by domain (genomic, digital, and clinical/organizational)

  At completion of the Delphi process (up to 4 months)

• Stability of responses across successive rounds (assessment of changes in CVI)

  Between successive Delphi rounds, until completion of the process (up to 4 months)

Study Arms (1)

INNOPREV expert panel

Professionals involved in the INNOPREV project with expertise in cardiology, personalized medicine, and/or digital health will be invited to participate. Enrollment will occur by invitation only, contingent upon provision of electronic informed consent. A panel of at least 10 experts is planned

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A panel of at least 10 experts will be recruited from professionals involved in the INNOPREV project (internal and/or external members) with expertise in cardiology, personalized medicine, and/or digital health. Participation will be by email invitation and will require acceptance of the informed consent form (exclusion criterion: failure to provide informed consent)

You may qualify if:

• Experts in cardiology
• Experts in personalized medicine
• Experts in digital health.

You may not qualify if:

• \- Failure to provide informed consent (i.e., non-acceptance of the informed consent form)

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Policlinico Universitario Fondazione Agostino Gemelli IRCCS

Roma, RM, 00168, Italy

Location

MeSH Terms

Conditions

Genetic Risk Score; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Genetic Predisposition to Disease; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• STEFANIA BOCCIA, PHD

  Policlinico Universitario Fondazione Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

STEFANIA BOCCIA, PHD

CONTACT

+390630154396; stefania.boccia@unicatt.it

LUIGI RUSSO, MD

CONTACT

luigi.russo12@icatt.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 22, 2026
• Study Start: February 1, 2026
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

IT (1)