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NCT Number: NCT07358481

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

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%)

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Policlinico Universitario Fondazione Agostino Gemelli IRCCS

Roma, RM, 00168, Italy

Location contact

STEFANIA BOCCIA, PHD

CONTACT

[email protected]

+390630154396

About this study

The DEL-DIP project aims to develop operational recommendations to support the coordinated implementation of Polygenic Risk Scores (PRS) and wearable devices within cardiovascular prevention pathways, where the integration of genomics and digital health may enhance risk stratification and enable continuous monitoring.

The study adopts a Delphi methodology comprising anonymous, web-based rounds in which an expert panel rates its level of agreement with a series of proposed recommendations. Following each round, responses are aggregated and summarized, and the items are re-circulated to allow participants to reconsider and refine their judgments in light of group feedback, thereby facilitating iterative convergence toward consensus.

Data are collected via Microsoft Forms and centralized for analysis. Safeguards are implemented to ensure data security, anonymity, and privacy, and electronic informed consent is obtained prior to questionnaire access.

For each item, the Content Validity Index (CVI) is calculated as the proportion of experts assigning a rating of 4 or 5. A CVI > 79% indicates consensus and supports item inclusion; CVI values between 70% and 79% indicate partial agreement and the need for item revision and/or additional Delphi rounds; values < 70% suggest item exclusion.

The final output will consist of a set of recommendations organized by domain (genomic, digital, and clinical/organizational), together with an assessment of response stability across successive rounds (i.e., changes in CVI), to inform implementation within healthcare services.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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)

    Time frame: 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

Secondary outcomes

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

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

    Identification of items/recommendations with a Content Validity Index (CVI) between 70% and 79%, indicating the need for item revision and/or additional Delphi rounds

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

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

    Production of the final set of recommendations, organized by domain (genomic, digital, and clinical/organizational)

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

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

    Assessment of response stability by comparing, for each item, changes in the CVI across successive Delphi rounds

Study contacts

Contact information is provided by the study sponsor or research team.

LUIGI RUSSO, MD

CONTACT

[email protected]

STEFANIA BOCCIA, PHD

CONTACT

[email protected]

+390630154396

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

DEL-DIP: DELphi Procedure for Developing Recommendations for the Implementation of Wearable Devices and Polygenic Risk Scores

Acronym: DEL-DIP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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