Surrogating Physician-recorded SCORE2 Risk Calculator Inputs by Using Auxiliary Data
Recruiting now
Conditions studied: Cardiovascular Diseases, Menopause
In brief
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.
Key facts
- Study ID
- NCT06831890
- Run by
- Insel Gruppe AG, University Hospital Bern
- People needed
- 250
- Starts
- 2023-08-24
- Expected to finish
- 2025-03-01
- Last updated by the study team
- 2025-02-18
Who can join
Age: 40 and older, up to 69. Sex: female. Healthy volunteers: accepted.
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.
Where it is running
- University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine — Bern, Switzerland (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.