Surrogating Physician-recorded SCORE2 Risk Calculator Inputs by Using Auxiliary Data

NCT ID: NCT06831890

Last Updated: 2025-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-24

Study Completion Date

2025-03-31

Brief Summary

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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:

* 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.

Detailed Description

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Conditions

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Cardiovascular Diseases Menopause

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Apparently healthy women aged 40 to 69 years

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

69 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Petra Stute, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine

Locations

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University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine

Bern, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Petra Stute, Prof.

Role: CONTACT

+41 31 632 1010

Facility Contacts

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Petra Stute, Prof.

Role: primary

+41 31 632 1010

Other Identifiers

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2022-02080

Identifier Type: -

Identifier Source: org_study_id

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