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Status unknownNCT03403673Updated Jan 19, 2018

Clinical Frailty Scale Validation in Patients Scheduled for Vascular Surgery

An observational study in Vascular Diseases, sponsored by South Tees Hospitals NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2018-01-19.

Sponsored by South Tees Hospitals NHS Foundation Trust · Observational

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
60 Years and older
Sex
All
01

Study summary

Major vascular operations put the body under stress. We are trying to find out if the general health of a patient and the stress resulting from surgery can lead to the development of complications after surgery as well as increase the length of time spent in hospital.

There is evidence to suggest that patients who are frail have a higher risk of developing complications after major surgery.

Our aim is to ask you simple questions about your physical ability to perform daily life activities, assess your general health condition and ask you to do simple tasks such as drawing a clock or walking for a short distance to assess your speed of walking. Our main aim is to identify a tool that will assist us to identify patients who are at risk of frailty.

02

Conditions studied

  • Vascular Diseases
03

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All vascular patients attending the preoperative assessment clinics.

Eligibility criteria

Inclusion Criteria: Patients attending vascular pre assessment clinic Age > 60 -

Exclusion Criteria: Refusal or inability to provide informed consent. Patients under 60 years of age. Patients not undergoing a vascular procedure.

-

04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • OtherFrailty assessment tools

    There is evidence to suggest that patients who are frail have a higher risk of developing complications after major surgery. Our aim is to ask you simple questions about your physical ability to perform daily life activities, assess your general health condition and ask you to do simple tasks such as drawing a clock or walking for a short distance to assess your speed of walking. Our main aim is to identify a tool that will assist us to identify patients who are at risk of frailty

05

What researchers measure

Primary outcomes

  1. Clinical frailty scale validation in preoperative assessment of patients scheduled for vascular surgery

    Identify a tool that will assist us to identify patients who are at risk of frailty.

    Time frame: June 2018

06

Study locations

1 of 1 sites recruiting
07

References and documents

Publications

  • Ayyash R, Knight J, Kothmann E, Eid M, Ayyash K, Colling K, Yates D, Mill A, Danjoux G. Utility and reliability of the Clinical Frailty Scale in patients scheduled for major vascular surgery: a prospective, observational, multicentre observer-blinded study. Perioper Med (Lond). 2022 Jan 31;11(1):6. doi: 10.1186/s13741-022-00240-9. PubMed 35101117 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03403673
Lead sponsor
South Tees Hospitals NHS Foundation Trust
Responsible party
Sponsor
First posted
Jan 19, 2018
Start date
Apr 26, 2017
Primary completion
Jun 30, 2018 (estimated)
Completion
Jun 30, 2018 (estimated)
Last update
Jan 19, 2018

Study contacts

Reema Ayyash
Contact
reema.ayyash@stees.nhs.uk
01642 854600
Kerry Colling
Contact
kerrycolling@nhs.net
01642 854271

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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