Surrogating Physician-recorded SCORE2 Risk Calculator Inputs by Using Auxiliary Data

What this trial studies

The goal of the clinical trial is to assess whether the data collected from wearable devices can reduce the uncertainty in predicting the cardiovascular disease (CVD) risk in women aged 40-69 years in a situation where information about the blood pressure and blood lipids are unavailable. Participants will: * Complete a screening and baseline assessment, including blood sample collection and vital parameter measurement. * Wear a wearable device for one week. * Fill in a work and sleep journal.

Conditions in scope

• Cardiovascular Diseases
• Menopause

Interventions

• Not specified in the public record.

Who can join

Women only · Ages 40 Years to 69 Years · Accepts healthy volunteers.

Inclusion criteria

• Fluency in German (written and oral).
• Ownership of a smartphone.
• Signing the informed consent form.

Exclusion criteria

• Diagnosis of cardiovascular disease.
• Diagnosis of diabetes mellitus.
• Diagnosis of chronic kidney disease.
• Diagnosis of familial hypercholesterolemia.
• Incapable of providing informed consent.
• Current employment at the Section Gynecological Endocrinology and Reproductive Medicine of the Department for Obstetrics and Gynecology at the Inselspital Bern or any other professional relation to one of the study project leaders / investigators.
• Concurrent participation in a clinical intervention study.
• Inability to comply with the study procedures for any reason, including language comprehension, psychiatric illness, general inability to get to the study site.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Observational
• Phase: N/A
• Start date: 2023-08-24
• Primary completion: 2025-03
• Last update posted: 2025-02-18
• First posted: 2025-02-18

Sponsor & contact

Lead sponsor: Insel Gruppe AG, University Hospital Bern (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Reduction in CVD Risk Prediction Uncertainty Using Wearable Data (After 7-day wearable data collection period.)
  Assessment of the reduction in prediction uncertainty of cardiovascular disease (CVD) risk in women aged 40-69 years when wearable-derived data (e.g., heart rate, daily step count) is used to replace missing physician-recorded inputs (e.g., blood pressure and lipid levels). The reduction will be quantified using the Continuous Ranked Probability Score (CRPS), whereby smaller CRPS values indicate improved performance. An improvement…

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