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.
Eligibility
Sex
FEMALE
Min age
40 Years
Max age
69 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
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 is considered substantial if introducing wearable data reduces CRPS by at least 5%.
Trial sites (1)
Facility
City
Region
Status
University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine
Bern
Switzerland
Recruiting
More Insel Gruppe AG, University Hospital Bern trials in Switzerland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
