Wearable Electronic DevicesDEL-DIPNCT07358481
DELphi Procedure for Developing Recommendations for the Implementation of Wearable Devices and Polygenic Risk Scores
An observational study of Wearable Electronic Devices and Polygenic Risk Score, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Wearable Electronic Devices, Polygenic Risk Score, CVD - Cardiovascular Disease
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2026to Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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)
Who may be able to join
- Experts in cardiology
- Experts in personalized medicine
- Experts in digital health.
Who cannot join
- Failure to provide informed consent (i.e., non-acceptance of the informed consent form)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
LUIGI RUSSO, MD contact
Italy1 site
Policlinico Universitario Fondazione Agostino Gemelli IRCCS
Roma, RM, 00168
STEFANIA BOCCIA, PHD, +390630154396, stefania.boccia@unicatt.it
About this study
Official title: DEL-DIP: 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%)
Read the detailed description
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.
- Conditions
- Wearable Electronic Devices, Polygenic Risk Score, CVD - Cardiovascular Disease, Primary Prevention
- Keywords
- cardiovascular prevention
- Medical subject headings
- Genetic Risk Score, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the end of the Delphi process (up to 4 months)
Secondary outcomes (3)
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
Measured: 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)
Production of the final set of recommendations, organized by domain (genomic, digital, and clinical/organizational)
Measured: At completion of the Delphi process (up to 4 months)
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
Measured: Between successive Delphi rounds, until completion of the process (up to 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wearable Electronic DevicesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- STEFANIA BOCCIA, PHD, Principal investigator, Policlinico Universitario Fondazione Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358481
- Sponsor's protocol ID
- 8217
- Acronym
- DEL-DIP
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEL-DIP: DELphi Procedure for Developing Recommendations for the Implementation of Wearable Devices and Polygenic Risk Scores
- ClinicalTrials.gov ID
- NCT07358481
- Acronym / sponsor ID
- DEL-DIP / 8217
- Conditions
- Wearable Electronic Devices, Polygenic Risk Score, CVD - Cardiovascular Disease, Primary Prevention
- Keywords
- cardiovascular prevention
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%)
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (3 listed)
- Experts in cardiology
- Experts in personalized medicine
- Experts in digital health.
Key exclusion criteria (1 listed)
- Failure to provide informed consent (i.e., non-acceptance of the informed consent form)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Identification of recommendations with partial agreement (CVI 70-79%)
Time frame: 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)
Time frame: At completion of the Delphi process (up to 4 months)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
LUIGI RUSSO, MD contact
STEFANIA BOCCIA, PHD principal investigator
Policlinico Universitario Fondazione Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wearable Electronic Devices and Polygenic Risk Score, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact STEFANIA BOCCIA, PHD (+390630154396, stefania.boccia@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026; AzTrials last refreshed its copy on 27 Oct 2026.