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

Insel Gruppe AG, University Hospital Bern

Status: Enrolling

Conditions: Menopause; Cardiovascular Diseases

Study type: Observational

Funder types: Other

Identifiers

NCT06831890

2022-02080

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: Female

Ages: 40 to 69 years old

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

Trial design

250 participants in 1 patient group

Apparently healthy women aged 40 to 69 years