Frailty Assessment in Vascular Hot Clinic Setting - Feasibility and Prognostic Value

NCT ID: NCT06040658

Last Updated: 2023-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-15

Study Completion Date

2024-11-01

Brief Summary

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A single-centre prospective study of feasibility assessing the suitability of introducing routine frailty screening in a controlled, and reproducible, outpatient department setting for Vascular Surgery patients. This study will also perform head-to-head comparisons of the prognostic value of five frailty assessment tools, selected based on the previous demonstration of their popularity and familiarity within the speciality, their designs being based on different theories of frailty and that some are endorsed by local healthcare police. Inter-user variability (patient self assessment and clinician assessment will also be compared).

Detailed Description

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This single-centre prospective cohort study of feasibility, is conducted in a rapid-referral vascular surgery clinic, serving a population of 2 million. Capax adults (\>18years), attending clinic for any reason are eligible for inclusion. Five frailty assessments are completed at the clinic by patient (Rockwood Clinical Frailty Scale \[CFS\] and Frail NonDisabled Questionnaire \[FiND\]), clinician (CFS, Health care Improvement Scotland FRAIL Scale and 'Initial Clinical Evaluation') and researcher (11-item modified Frailty Index, mFI-11). Consistent with feasibility objectives, outcome measures include recruitment rates, frailty assessment completion rates, time-to-complete assessments and inter-rater variability. Electronic follow-up at 30-days and 1-year will assess home-time and mortality as prognostic indicators. Patients treated surgically/endovascularly will undergo additional 30-day and 1-year post-operative follow-up, outcome measures include: surgical procedure, mortality, complications (according to Clavien-Dindo Classification), length-of-stay, readmission rates, non-home discharge, home-time, higher social care requirements on discharge and amputation-free survival. Prognostic value will be compared by area under Receiver operator characteristic (ROC) curves. Continuous outcome variables will be analysed using Spearman's rank correlation coefficient. Inter-user agreement will be compared by percentage agreement in Cohen's Kappa coefficient.

Conditions

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Frailty Frail Elderly Syndrome Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Vascular 'hot' clinic.

All adults (aged \> 17 years) referred to an urgent-referral, consultant-led, Vascular Surgery outpatient clinic, who have capacity, will be eligible for inclusion in this study.

Frailty assessment

Intervention Type DIAGNOSTIC_TEST

Rockwood Clinical Frailty Scale

Frailty assessment

Intervention Type DIAGNOSTIC_TEST

Frail NonDisabled Questionnaire (FiND)

Frailty assessment

Intervention Type DIAGNOSTIC_TEST

Clinician's subjective 'end-of-bed' test

Frailty assessment

Intervention Type DIAGNOSTIC_TEST

Healthcare Improvement Scotland FRAIL Scale

Frailty assessment

Intervention Type DIAGNOSTIC_TEST

11-item modified Frailty Index (mFI-11)

Interventions

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Frailty assessment

Rockwood Clinical Frailty Scale

Intervention Type DIAGNOSTIC_TEST

Frailty assessment

Frail NonDisabled Questionnaire (FiND)

Intervention Type DIAGNOSTIC_TEST

Frailty assessment

Clinician's subjective 'end-of-bed' test

Intervention Type DIAGNOSTIC_TEST

Frailty assessment

Healthcare Improvement Scotland FRAIL Scale

Intervention Type DIAGNOSTIC_TEST

Frailty assessment

11-item modified Frailty Index (mFI-11)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Adults (aged 18 years or older)
* Attending Vascular Hot Clinic

Exclusion Criteria

* Lacking capacity to provide informed consent
* Parent clinical team feel frailty assessment not suitable
* Non-English speaker without qualified translator present
* Prisoners
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Glasgow

OTHER

Sponsor Role lead

Responsible Party

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Silje Welsh

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Quinn

Role: STUDY_DIRECTOR

University of Glasgow

Locations

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Queen Elizabeth University Hospital

Glasgow, Lanarkshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Welsh

Role: CONTACT

07786123590

Facility Contacts

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Welsh

Role: primary

References

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Welsh SA, Hussey K, Brittenden J, Orr DJ, Quinn T. Frailty Assessment in Vascular OUtpatients Review (FAVOUR) protocol: single-centre prospective cohort study comparing feasibility and prognostic value of commonly used frailty assessment tools. BMJ Open. 2023 Dec 9;13(12):e079387. doi: 10.1136/bmjopen-2023-079387.

Reference Type DERIVED
PMID: 38070914 (View on PubMed)

Other Identifiers

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GN23CE014

Identifier Type: -

Identifier Source: org_study_id

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