NCT06831890 Surrogating Physician-recorded SCORE2 Risk Calculator Inputs by Using Auxiliary Data
| NCT ID | NCT06831890 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Cardiovascular Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2023-08-24 |
| Primary Completion | 2025-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2023-08-24 with a primary completion date of 2025-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 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.
Contact & Investigator
Petra Stute, Prof.
PRINCIPAL INVESTIGATOR
University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine
Frequently Asked Questions
Who can join the NCT06831890 clinical trial?
This trial is open to female participants only, aged 40 Years or older, up to 69 Years, studying Cardiovascular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06831890 currently recruiting?
Yes, NCT06831890 is actively recruiting participants. Contact the research team at petra.stute@insel.ch for enrollment information.
Where is the NCT06831890 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT06831890 clinical trial?
NCT06831890 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Petra Stute, Prof. at University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine. The trial plans to enroll 250 participants.