FrailtyFAVOURNCT06040658
Frailty Assessment in Vascular Hot Clinic Setting - Feasibility and Prognostic Value
An observational study of Frailty and Frail Elderly Syndrome, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty, Frail Elderly Syndrome, Surgery
- What is being tested?
- Frailty assessment
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Mar 2023to 1 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All referrals to vascular hot clinic are eligible for inclusion, preferentially recruiting new referrals. As frailty is related to age, but does not directly correlate with it, no age cut-off has been defined. As this is primarily a study of feasibility, patients will not be excluded/included based on presenting symptom or diagnosed pathology. A proxy (relative/friend/carer), if present, will also be invited to participate and assist with frailty assessments of the patients, where suitable. The participation of the proxy is dependent on the patient providing written consent agreeing to their participation, as well as the proxy being eligible to participate, according to the same inclusion/exclusion criteria set out for patients below.
Who may be able to join
- Adults (aged 18 years or older)
- Attending Vascular Hot Clinic
Who cannot join
- Lacking capacity to provide informed consent
- Parent clinical team feel frailty assessment not suitable
- Non-English speaker without qualified translator present
- Prisoners
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Queen Elizabeth University Hospital
Glasgow, Lanarkshire, G51 4TF
Welsh, silje.welsh@glasgow.ac.uk
About this study
Official title: Frailty Assessment in Vascular OUtpatients Review (FAVOUR Trial) - Comparing Feasibility and Prognostic Value of Commonly Used Assessments
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).
Read the detailed description
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
- Frailty, Frail Elderly Syndrome, Surgery
- Being tested
- Frailty assessment
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frailty assessmentDiagnostic test
Rockwood Clinical Frailty Scale
Frailty assessmentDiagnostic test
Frail NonDisabled Questionnaire (FiND)
Frailty assessmentDiagnostic test
Clinician's subjective 'end-of-bed' test
Frailty assessmentDiagnostic test
Healthcare Improvement Scotland FRAIL Scale
Frailty assessmentDiagnostic test
11-item modified Frailty Index (mFI-11)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Frailty assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of implementing routine frailty assessment in a vascular clinic setting
Proportion of patients recruited (Number of recruited patients/[number of patients attending clinic - number of ineligible patients]).
Measured: During participant recruitment, over up to 4 months.
Frailty assessment completion time
Time taken to complete assessments (presented in seconds). The less time taken, the better.
Measured: During participant recruitment, over up to 4 months.
Frailty assessment completion rates
Proportion of assessments with non-completion. Calculated by: number of incomplete frailty assessments/total number of recruited patients, the lower the value the better.
Measured: During participant recruitment, over up to 4 months.
Secondary outcomes (9)
Assessing the prognostic value of selected frailty assessment tools (Home time - all patients)
'Home time': this describes the number of full days at home (not as a hospital inpatient) over the follow up periods. All recruited patients will undergo this follow-up.
Measured: 30-days and 1 year from recruitment/clinic attendance
Assessing the prognostic value of selected frailty assessment tools (Mortality - all patients)
Mortality: this will be calculated from date of recruitment. All recruited patients will undergo this follow-up.
Measured: 30-days and 1 year from recruitment/clinic attendance
Assessing the peri-operative prognostic value of selected frailty assessment tools (Mortality)
For patients offered endovascular/surgical/hybrid intervention: mortality. Proportion of patients dead at follow up.
Measured: 30-days and 1 year from primary intervention offered following recruitment to study.
Assessing the peri-operative prognostic value of selected frailty assessment tools (Complications)
For patients offered endovascular/surgical/hybrid intervention: post-operative complications (according to the Clavien-Dindo Classification).
Measured: 30-days and 1 year from primary intervention offered following recruitment to study.
Assessing the peri-operative prognostic value of selected frailty assessment tools (Length of stay)
For patients offered endovascular/surgical/hybrid intervention: length of hospital stay (full days). Calculated as number of full days as inpatient following admission for index procedure.
Measured: 30-days and 1 year from primary intervention offered following recruitment to study.
Assessing the peri-operative prognostic value of selected frailty assessment tools (Readmission)
For patients offered endovascular/surgical/hybrid intervention: readmission rates (to any speciality). This will be calculated by the proportion of patients readmitted to hospital following index procedure/the number of patients undergoing surgical/endovascular treatment.
Measured: 30-days from primary intervention offered following recruitment to study.
Assessing the peri-operative prognostic value of selected frailty assessment tools (Non-home discharge)
For patients offered endovascular/surgical/hybrid intervention: non-home discharge. This will be calculated by the proportion of patients who are discharged to place of residence differing from their preoperative residence/total number of patients undergoing surgical/endovascular treatment. For example, from private residence preoperatively to care home.
Measured: 30-days from primary intervention offered following recruitment to study.
Assessing the peri-operative prognostic value of selected frailty assessment tools (Home time)
For patients offered endovascular/surgical/hybrid intervention: home time. See outcome 4.
Measured: 30-days and 1 year from primary intervention offered following recruitment to study.
Assessing the peri-operative prognostic value of selected frailty assessment tools (Social care requirements)
For patients offered endovascular/surgical/hybrid intervention: discharge with a higher level of social care requirements. This will be presented as the proportion of patients discharged with greater social care requirements than before their index admission/'total number of patients offered surgical or endovascular treatment. E.g., a patient is admitted preopertively with three times daily package of care and discharged with four times daily package of care
Measured: 30-days from primary intervention offered following recruitment to study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start15 Mar 2023
- Primary completion17 Jul 2023
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silje Welsh, University of Glasgow
- Investigators
- Quinn, Study director, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040658
- Sponsor's protocol ID
- GN23CE014
- Acronym
- FAVOUR
- Status last verified
- Sep 2023
- First submitted
- 1 Sep 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Pseudonymised research data will be uploaded to appropriate data registry
Publications
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.
PubMed 38070914
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty Assessment in Vascular OUtpatients Review (FAVOUR Trial) - Comparing Feasibility and Prognostic Value of Commonly Used Assessments
- ClinicalTrials.gov ID
- NCT06040658
- Acronym / sponsor ID
- FAVOUR / GN23CE014
- Conditions
- Frailty, Frail Elderly Syndrome, Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 17 Jul 2023 (actual)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vascular 'hot' clinic. | – | Diagnostic Test: Frailty assessmentAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All referrals to vascular hot clinic are eligible for inclusion, preferentially recruiting new referrals. As frailty is related to age, but does not directly correlate with it, no age cut-off has been defined. As this is primarily a study of feasibility, patients will not be excluded/included based on presenting symptom or diagnosed pathology. A proxy (relative/friend/carer), if present, will also be invited to participate and assist with frailty assessments of the patients, where suitable. The participation of the proxy is dependent on the patient providing written consent agreeing to their participation, as well as the proxy being eligible to participate, according to the same inclusion/exclusion criteria set out for patients below.
Key inclusion criteria (2 listed)
- Adults (aged 18 years or older)
- Attending Vascular Hot Clinic
Key exclusion criteria (4 listed)
- Lacking capacity to provide informed consent
- Parent clinical team feel frailty assessment not suitable
- Non-English speaker without qualified translator present
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frailty assessmentRockwood Clinical Frailty Scale | Diagnostic test | Vascular 'hot' clinic. |
| Frailty assessmentFrail NonDisabled Questionnaire (FiND) | Diagnostic test | Vascular 'hot' clinic. |
| Frailty assessmentClinician's subjective 'end-of-bed' test | Diagnostic test | Vascular 'hot' clinic. |
| Frailty assessmentHealthcare Improvement Scotland FRAIL Scale | Diagnostic test | Vascular 'hot' clinic. |
| Frailty assessment11-item modified Frailty Index (mFI-11) | Diagnostic test | Vascular 'hot' clinic. |
Primary outcome
Feasibility of implementing routine frailty assessment in a vascular clinic setting
Time frame: During participant recruitment, over up to 4 months.
Proportion of patients recruited (Number of recruited patients/[number of patients attending clinic - number of ineligible patients]).
Frailty assessment completion time
Time frame: During participant recruitment, over up to 4 months.
Time taken to complete assessments (presented in seconds). The less time taken, the better.
Frailty assessment completion rates
Time frame: During participant recruitment, over up to 4 months.
Proportion of assessments with non-completion. Calculated by: number of incomplete frailty assessments/total number of recruited patients, the lower the value the better.
9 secondary outcomes
Assessing the prognostic value of selected frailty assessment tools (Home time - all patients)
Time frame: 30-days and 1 year from recruitment/clinic attendance
Assessing the prognostic value of selected frailty assessment tools (Mortality - all patients)
Time frame: 30-days and 1 year from recruitment/clinic attendance
Assessing the peri-operative prognostic value of selected frailty assessment tools (Mortality)
Time frame: 30-days and 1 year from primary intervention offered following recruitment to study.
Assessing the peri-operative prognostic value of selected frailty assessment tools (Complications)
Time frame: 30-days and 1 year from primary intervention offered following recruitment to study.
Assessing the peri-operative prognostic value of selected frailty assessment tools (Length of stay)
Time frame: 30-days and 1 year from primary intervention offered following recruitment to study.
Assessing the peri-operative prognostic value of selected frailty assessment tools (Readmission)
Time frame: 30-days from primary intervention offered following recruitment to study.
Assessing the peri-operative prognostic value of selected frailty assessment tools (Non-home discharge)
Time frame: 30-days from primary intervention offered following recruitment to study.
Assessing the peri-operative prognostic value of selected frailty assessment tools (Home time)
Time frame: 30-days and 1 year from primary intervention offered following recruitment to study.
Assessing the peri-operative prognostic value of selected frailty assessment tools (Social care requirements)
Time frame: 30-days from primary intervention offered following recruitment to study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Derived from this study: PubMed 38070914Welsh 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.
- Individual participant dataSharing planned: Undecided. Pseudonymised research data will be uploaded to appropriate data registry
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Quinn study director
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and Frail Elderly Syndrome, run by University of Glasgow at 1 site in United Kingdom.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 15 Sep 2023. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Welsh (07786123590, silje.welsh@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of implementing routine frailty assessment in a vascular clinic setting (time frame: During participant recruitment, over up to 4 months.). The study lists 3 primary outcomes in all. 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 NCT06040658, which also lists 1 linked publication.
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 15 Sep 2023.