Using wearable data to improve cardiovascular risk predictions in women
Surrogating Physician-recorded SCORE2 Risk Calculator Inputs by Using Auxiliary Data - A Cross-sectional Study in Apparently Healthy Women Aged 40 to 69 Years (Frauenherzen)
This study is testing if information from wearable devices can help better predict heart disease risk in women aged 40-69 when usual health measurements aren't available.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 40 Years to 69 Years |
| Sex | Female |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT06831890 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate whether data from wearable devices can enhance the accuracy of predicting cardiovascular disease risk in women aged 40-69 when traditional metrics like blood pressure and lipid levels are not available. Participants will undergo a screening process, wear a device for a week, and maintain a work and sleep journal. The study will assess the effectiveness of these auxiliary data inputs in refining risk assessments for cardiovascular diseases and menopause-related health issues.
Who should consider this trial
Good fit: Ideal candidates are women aged 40-69 who are fluent in German and own a compatible smartphone.
Not a fit: Patients with existing cardiovascular diseases, diabetes, chronic kidney disease, or familial hypercholesterolemia will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate cardiovascular risk assessments for women, potentially improving preventive care.
How similar studies have performed: While the use of wearable devices in health monitoring is gaining traction, this specific approach to enhancing cardiovascular risk prediction is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bern
- University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Petra Stute, Prof. — University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine
- Study coordinator: Petra Stute, Prof.
- Email: petra.stute@insel.ch
- Phone: +41 31 632 1010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.