Comparison of Preoperative Frailty Assessment Tools (PREFAS)

Evaluation of a Feasible Frailty Assessment Tool for Preoperative Risk Evaluation of Older Patients

Frailty is a significant risk factor for postoperative complications and functional decline. Preoperative assessment of frailty is therefore recommended in all older adults. However, despite the availability of many frailty tools, few have been tested in the preoperative setting and there is little comparison of their predictive value in identifying patients at risk. The aim of this study is to investigate which of the following instruments for determining frailty has the highest predictive power with regard to the occurrence of postoperative complications: Risk Analysis Index, Clinical Frailty Scale, the Groningen Frailty Indicator, the Edmonton Frail Scale and the LUCAS-FI. The aim of this research project is to identify a suitable frailty instrument for preoperative risk stratification of older patients during the premedication visit.

Study Overview

• Status: Not yet recruiting
• Conditions: Frailty; Frailty/Sarcopenia; Frailty in Older Adults
• Intervention / Treatment: Other: Assessment of frailty using multiple tools

• Study Type: Observational
• Enrollment (Estimated): 584

Contacts and Locations

• Study Contact: Name: Dr. Cynthia Olotu, MD; Phone Number: 0049 40 7410 52415; Email: c.olotu@uke.de

Study Locations

• Germany
  • Hamburg, Germany, 22046
    • University Medical Centre Hamburg
    • Contact: Dr. Silke Schrum; Phone Number: 0049 40 7410 54290; Email: s.schrum@uke.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients of the Medical University Centre Hamburg, Germany

Description

Inclusion Criteria:

• 70 years and older
• scheduled surgery
• estimated time of surgery 120 Minutes or more

Exclusion Criteria:

• insufficient German language skills (for cognitive testing)
• mental retardation
• relevant psychiatric disorder (not allowing for cognitive testing)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Older patients; Patients at 70 years and above scheduled for surgery	Other: Assessment of frailty using multiple tools; This is an observational study without any intervention. Frailty is assessed using multiple tools and postoperative outcome is compared.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications in the first 30 days after surgery	Measured by Clavien-Dindo classification	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional state (activities of daily living)	Measured using WHO Disability Assessment Schedule 2.0	one, three and six months after surgery
Postoperative Quality of Recovery	Measured by Quality-of-Recovery-15 questionnaire	postoperative day 2
Muscle loss during hospitalisation	measured by bioimpedance prior to admission and before discharge from hospital	From date of enrollment, up to 4 weeks after surgery
Postoperative delirium	Measured by 3D-Confusion Assessment Method	postoperative day 1 to 5
Length of stay	days spent in hospital after surgery	from day of surgery, up to 4 weeks after surgery
Discharge destination	e.g.:home, nursing home, other hospital	up to 4 weeks after surgery
Cognitive state	Using 5-Minute Montreal Cognitive Assessment (telephone-MOCA). A maximum of 15 points and a minumum of 0 points can be archieved; a higher score indicates better cognitive performance.	3 and 6 months after surgery
Quality-of-Life (QoL)	Measured by WHO-Quality of Life in older adults (WHOQOL-OLD) questionnaire. The WHOQOL-OLD is evaluated by calculating scores for its six facets and summing them, with higher scores indicating a better perceived quality of life.	3 and 6 months after surgery
Frailty progression measured by LUCAS-FI	Frailty assessment with Longitudinal Urban Cohort Aging Study Functional Index (LUCAS-FI)-questionnaire (telephone interview) The LUCAS-FI is evaluated by integrating both risk factors and protective resources, with the balance between them determining the degree of frailty.	3 and 6 months after surgery
Frailty progression measured by GFI (questionnaire)	frailty assessment with Groningen Frailty Indicator (GFI) questionnaire (telephone interview). The GFI is evaluated by summing its item responses, with higher scores indicating a higher degree of frailty.	3 and 6 months after surgery
Frailty progression measured by EFS	Frailty assessment by Edmonton Frail Scale (EFS), (score filled by physician, patient telephone interview). 1 to 10 points can be archieved, more points indicate a greater level of frailty.	3 and 6 months after surgery
Frailty progression by RAI measurement. The Risk Analysis Index (RAI) is evaluated by summing weighted risk factors and protective variables, with higher scores indicating greater patient vulnerability.	Frailty assessment with Risk Analysis Index (index filled by physician, patient telephone interview)	3 and 6 months after surgery

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Dr. Cynthia Olotu, MD, University Medical Centre Hamburg

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: February 23, 2025
• First Submitted That Met QC Criteria: March 16, 2025
• First Posted (Actual): March 21, 2025

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 30, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathologic Processes; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Frailty; Sarcopenia
• Other Study ID Numbers: 2024-101410-BO-ff

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Strict data protection guidelines prevent patient data from being made available to third parties. In specific cases, anonymised data may be provided after individual examination and consultation with the responsible ethics committee.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No