FrailtyPREFASNCT06889545
Comparison of Preoperative Frailty Assessment Tools
An observational study of Frailty and Frailty in Older Adults, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Frailty, Frailty in Older Adults, Frailty/Sarcopenia
- What is being tested?
- Assessment of frailty using multiple tools
- How many people
- 584 participants
- Where
- 1 siteGermany
- Study dates
- 15 Apr 2025to 1 Apr 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients of the Medical University Centre Hamburg, Germany
Who may be able to join
- 70 years and older
- scheduled surgery
- estimated time of surgery 120 Minutes or more
Who cannot join
- insufficient German language skills (for cognitive testing)
- mental retardation
- relevant psychiatric disorder (not allowing for cognitive testing)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Medical Centre Hamburg
Hamburg, 22046
Dr. Silke Schrum, 0049 40 7410 54290, s.schrum@uke.de
About this study
Official title: 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.
- Conditions
- Frailty, Frailty in Older Adults, Frailty/Sarcopenia
- Being tested
- Assessment of frailty using multiple tools
- Medical subject headings
- Frailty, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of frailty using multiple toolsOther
This is an observational study without any intervention. Frailty is assessed using multiple tools and postoperative outcome is compared.
| Study group | Role | What they receive |
|---|---|---|
| Older patients | Patients at 70 years and above scheduled for surgery Receives: Other: Assessment of frailty using multiple tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications in the first 30 days after surgery
Measured by Clavien-Dindo classification
Measured: 30 days
Secondary outcomes (12)
Functional state (activities of daily living)
Measured using WHO Disability Assessment Schedule 2.0
Measured: one, three and six months after surgery
Postoperative Quality of Recovery
Measured by Quality-of-Recovery-15 questionnaire
Measured: postoperative day 2
Muscle loss during hospitalisation
measured by bioimpedance prior to admission and before discharge from hospital
Measured: From date of enrollment, up to 4 weeks after surgery
Postoperative delirium
Measured by 3D-Confusion Assessment Method
Measured: postoperative day 1 to 5
Length of stay
days spent in hospital after surgery
Measured: from day of surgery, up to 4 weeks after surgery
Discharge destination
e.g.:home, nursing home, other hospital
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 3 and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start15 Apr 2025
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 584 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Cynthia Olotu, MD, Principal investigator, University Medical Centre Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889545
- Sponsor's protocol ID
- 2024-101410-BO-ff
- Acronym
- PREFAS
- Status last verified
- Jul 2026
- First submitted
- 23 Feb 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.