Swiss Frailty Network and Repository

Fatigue Clinical Trial

— SFNR  

Official title:

Swiss Frailty Network and Repository

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04516642
• Other study ID #: SPHN Project-ID 2017DRI02
• Status: Active, not recruiting
• Start date: June 1, 2020
• Est. completion date: February 28, 2024

Study information

• Verified date: May 2023
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Physical frailty is an age-related medical syndrome defined by a decline in multiple body systems, thus causing increased vulnerability, even in the face of minor stressors (1) It has been linked to multiple negative health outcomes, including extended length of stay in acute care due to complications, hospital re-admissions, and mortality among older patients. About 10-30% of community-dwelling seniors are considered frail(2) with an additional 40% being at risk for the condition (pre-frailty). By 2030, the number of older adults with frailty is expected to at least double, in parallel to the projected growth of the older segment of the population. Frail seniors consume 3-times more health care resources then their robust counterparts. Thus, the health economic impact of frailty is expected to be enormous and a call to action has been posed. Big data in healthcare provides important opportunities for the identification of frailty among the growing number of older patients. This is relevant as frailty is considered a better predictor of adverse outcomes than chronological age alone. Therefore, several medical specialties have started to assess frailty in cancer patients, heart surgery candidates and potential organ transplant recipients.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: February 28, 2024
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Men and women age 65 and older

• Admission as inpatients to acute care at any partnering university hospital (eFI - subgroup)

• Admission as inpatients to acute geriatric care (cFI - subgroup)

• Patients or proxies need to provide a written informed consent (geriatric patients (cFI and eFI): project consent; non-geriatric patients ((eFI): general consent)

Exclusion Criteria:

• Documented objection of participating in the project and/or subsequent use of personal health data

• Not fluent in local language (i.e. German, French)

• Patient is uncooperative or presence of inability to perform functional tests due to severe cognitive and/or physical impairment/acute medical illness

Related Conditions & MeSH terms

• Fatigue
• Frailty
• Muscle Weakness
• Physical Frailty
• Weakness, Muscle
• Weight Loss

Locations

Country	Name	City	State
Switzerland	Dept. of Geriatrics and Aging Research, University of Zurich / Geriatric Clinic University Hospital Zurich	Zürich	ZH

Sponsors (5)

Lead Sponsor	Collaborator
University of Zurich	University Department of Geriatric Medicine FELIX PLATTER, University Hospital Inselspital, Berne, University Hospital, Geneva, University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive and negative predictive value of the eFI	Validation Study	year 2-3
Primary	sensitivity and specificity of the eFI	Validation Study	year 2-3
Primary	The correlation between the cFI and the eFI with length of stay and in-hospital mortality	Correlation Study	year 2-3