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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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
Are there results?
Not yet: the study is under way

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.

Dr. Cynthia Olotu, MD contact

0049 40 7410 52415

c.olotu@uke.de

Germany1 site, 1 recruiting

  • University Medical Centre Hamburg

    Hamburg, 22046

    Dr. Silke Schrum, 0049 40 7410 54290, s.schrum@uke.de

    Recruiting

Other trials in Germany

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.

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 groups in NCT06889545
Study groupRoleWhat they receive
Older patientsPatients 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.

  1. Complications in the first 30 days after surgery

    Measured by Clavien-Dindo classification

    Measured: 30 days

Secondary outcomes (12)

  1. Functional state (activities of daily living)

    Measured using WHO Disability Assessment Schedule 2.0

    Measured: one, three and six months after surgery

  2. Postoperative Quality of Recovery

    Measured by Quality-of-Recovery-15 questionnaire

    Measured: postoperative day 2

  3. 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

  4. Postoperative delirium

    Measured by 3D-Confusion Assessment Method

    Measured: postoperative day 1 to 5

  5. Length of stay

    days spent in hospital after surgery

    Measured: from day of surgery, up to 4 weeks after surgery

  6. Discharge destination

    e.g.:home, nursing home, other hospital

    Measured: up to 4 weeks after surgery

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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.

  1. First posted21 Mar 2025
  2. Study start15 Apr 2025
  3. Primary completion1 Nov 2027 (estimated)
  4. Study completion1 Apr 2028 (estimated)

Resources

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)
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.

Questions about this trial

What is this clinical trial studying?

An observational study of Frailty and Frailty in Older Adults, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dr. Cynthia Olotu, MD (0049 40 7410 52415, c.olotu@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complications in the first 30 days after surgery (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06889545.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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