Swiss Frailty Network and Repository

NCT04516642 | Unknown DMC

• 1 other identifier: SPHN Project-ID 2017DRI02
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Weight Loss; Fatigue; Physical Frailty; Weakness, Muscle

Keywords

Frailty; Frailty-Index

Outcome Measures

Primary Outcomes (3)

• Positive and negative predictive value of the eFI

  Validation Study

  year 2-3

• sensitivity and specificity of the eFI

  Validation Study

  year 2-3

• The correlation between the cFI and the eFI with length of stay and in-hospital mortality

  Correlation Study

  year 2-3

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hospitalized patients age 65 and older from all 5 university hospitals in Switzerland (Basel, Bern, Geneva, Lausanne and Zurich)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• Insel Gruppe AG, University Hospital Bern: collaborator
• University Department of Geriatric Medicine FELIX PLATTER: collaborator
• University Hospital, Geneva: collaborator
• University of Lausanne Hospitals: collaborator

Study Sites (1)

Dept. of Geriatrics and Aging Research, University of Zurich / Geriatric Clinic University Hospital Zurich

Zurich, Canton of Zurich, 8037, Switzerland

Location

Related Publications (1)

• Gagesch M, Edler K, Chocano-Bedoya PO, Abderhalden LA, Seematter-Bagnoud L, Meyer T, Bertschi D, Zekry D, Bula CJ, Gold G, Kressig RW, Stuck AE, Bischoff-Ferrari HA. Swiss Frailty Network and Repository: protocol of a Swiss Personalized Health Network's driver project observational study. BMJ Open. 2021 Jul 14;11(7):e047429. doi: 10.1136/bmjopen-2020-047429.

  PMID: 34261684 DERIVED

MeSH Terms

Conditions

Weight Loss; Fatigue; Muscle Weakness; Frailty

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes

Study Officials

• Heike Bischoff-Ferrari, MD, DrPH

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: August 18, 2020
• Study Start: June 1, 2020
• Primary Completion: May 30, 2023
• Study Completion: February 28, 2024
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: In order to ensure the same quality and standards between all 5 sites, data analysis, instructor training and project documents will be shared.
• Access Criteria: Personnel of the departments of geriatrics involved in our SFNR project at each center (Basel, USB and Felix Platter Spital\], Bern \[INSEL and Spital Tiefenau\], Geneva \[HUG\], Lausanne \[CHUV\] and Zurich \[USZ\]) and collaborating Research Data Warehouses of the aforementioned locations are entitled to pass on the personal data. In addition, the investigators entitle the responsible physicians of all involved acute care wards (i.e. general internal medicine and medical subspecialties, general surgery and surgical subspecialties, oncology, haematology, intensive care, neurology, dermatology, rheumatology, ophthalmology, emergency medicine, gynaecology, ENT/ORL, urology) at the partnering hospitals to pass on the routinely collected data for the eFI variables. A data transfer agreement will be established among all co-investigators before data transfer begins.

Locations

CH (1)