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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apparently healthy women aged 40 to 69 years |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of wearable data that improve cardiovascular disease risk prediction without clinical key inputs | Identifying specific data from wearable devices that most effectively reduce uncertainty in predicting CVD risk in the absence of information on blood pressure, blood lipids, and the presence or absence of metabolic syndrome. To achieve this, statistical and machine learning methods capable of handling irregularly samples time series of bio-signals recorded by the wearable devices will be applied. |
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Inclusion Criteria:
Exclusion Criteria:
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The study will include women aged 40 to 69 years who meet the inclusion and exclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Petra Stute, Prof. | Contact | +41 31 632 1010 | petra.stute@insel.ch |
| Name | Affiliation | Role |
|---|---|---|
| Petra Stute, Prof. | University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine | Recruiting | Bern | 3010 | Switzerland |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| After 7-day wearable data collection period. |