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

NCT06831890 | Recruiting DMC

• 1 other identifier: 2022-02080
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.
• Complete a last visit assessment.

Conditions

Cardiovascular Diseases; Menopause

Keywords

Menopause; Cardiovascular disease risk; Wearables; SCORE2; Health monitoring

Outcome Measures

Primary Outcomes (1)

• Reduction in CVD Risk Prediction Uncertainty Using Wearable Data

  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 is considered substantial if introducing wearable data reduces CRPS by at least 5%.

  After 7-day wearable data collection period.

Secondary Outcomes (1)

• Identification of wearable data that improve cardiovascular disease risk prediction without clinical key inputs

  After 7-day wearable data collection period.

Study Arms (1)

Apparently healthy women aged 40 to 69 years

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include women aged 40 to 69 years who meet the inclusion and exclusion criteria.

You may qualify if:

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

You may not qualify if:

• 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.
• Participant's smartphone not compatible with Fitrockr.
• Technical inability of participant's smartphone to connect to the smartwatch.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Petra Stute, Prof.

  University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Petra Stute, Prof.

CONTACT

+41 31 632 1010; petra.stute@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: February 18, 2025
• Study Start: August 24, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

CH (1)