Health TrialsbyHealthPanel

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

ConditionsWearable Electronic DevicesPolygenic Risk ScoreCVD - Cardiovascular DiseasePrimary Prevention
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Experts in cardiology

Experts in personalized medicine

Experts in digital health.

Disqualifiers

None

Trial 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)

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

10 Participants
are grouped into 1 trial group
Group A: INNOPREV expert panel

Trial outcomes

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

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

Secondary outcomes

1

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

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

Time frame
After each Delphi round, through completion of the process (up to 4 months)
2

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

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

Time frame
At completion of the Delphi process (up to 4 months)
3

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

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

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

Other outcomes

Sponsors and contacts

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: