Swiss Frailty Network and Repository (SFNR)
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|ClinicalTrials.gov Identifier: NCT04516642|
Recruitment Status : Active, not recruiting
First Posted : August 18, 2020
Last Update Posted : October 22, 2021
|Condition or disease|
|Weight Loss Fatigue Physical Frailty Weakness, Muscle|
The Swiss Frailty Network and Repository is a Swiss Personalized Health Network (SPHN) driver project. The investigators aim to promote the sustainable implementation of a frailty data network for research and clinical purposes in strong partnership between all Swiss geriatric academic centers.
One of the five main goals of this project is to validate an electronic frailty index (eFI) as a screening tool against a clinical frailty instrument (cFI) (validation study) and the investigation of the correlation of the two instruments with the important endpoints in-hospital mortality and length of stay in hospital (association study) is at the core of the project. For the validation study (4), the investigators will include patients 65 and older admitted to acute geriatric care at all partnering sites, where both, the cFI and the eFI is collected. For the validation study (4), the investigators will include only patients with written project informed consent and consent for subsequent use of the project data (the investigators will also ask for general consent whenever possible. For the correlation study (5) regarding the cFI and the 2 outcomes. The same requirements apply as for the validation study (4). For the association study (5) regarding the eFI screening tool, the investigators will utilize data from all patients age 65 and older admitted to acute care at all partnering sites. For the eFI, the investigators will only include participants with available written general consent for further use of routinely collected health data, or established permission for use in exceptional cases by an ethics committee (HRA Art. 34).
Due to time constraints and great complexity of the local integration of the clinical frailty instrument (cFI) as a reference measure at the five different clinic information systems, the investigators will only integrate the cFI into the primary system at University Hospital Zurich (USZ) during the three-year duration of the project. At all other partner sites, an electronic case report form in REDCap will be in place for data entry of the cFI assessment.
In summary, the investigators will categorize the collection of data for the clinical Frailty Instrument (cFI) and the electronic Frailty Index (eFI) screening tool in geriatric inpatients 65 years and older (validation study plus correlation study) at all sites as a category A research project (not a clinical trial) with only minimal risks at all partner sites and the collection of the eFI screening tool in all other acute care patients 65 years and older as a further use of non-genetic personal health data in patients where a general consent is available.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1500 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||Swiss Frailty Network and Repository|
|Actual Study Start Date :||June 1, 2020|
|Estimated Primary Completion Date :||February 28, 2022|
|Estimated Study Completion Date :||February 28, 2022|
- Positive and negative predictive value of the eFI [ Time Frame: year 2-3 ]Validation Study
- sensitivity and specificity of the eFI [ Time Frame: year 2-3 ]Validation Study
- The correlation between the cFI and the eFI with length of stay and in-hospital mortality [ Time Frame: year 2-3 ]Correlation Study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04516642
|Dept. of Geriatrics and Aging Research, University of Zurich / Geriatric Clinic University Hospital Zurich|
|Zürich, ZH, Switzerland, 8037|
|Principal Investigator:||Heike Bischoff-Ferrari, MD, DrPH||University of Zurich|