FINE-ST: Frailty and inequality in stroke

ISRCTN	ISRCTN11241011
DOI	https://doi.org/10.1186/ISRCTN11241011
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	273619
Protocol serial number	IRAS 273619, CPMS 44689
Sponsor	University of Nottingham
Funder	NIHR CRN East Midlands

Submission date: 28/06/2021
Registration date: 21/03/2022
Last edited: 21/03/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Stroke is the commonest cause of neurological disability and death in the UK (>100,000 per year). The majority of strokes occur in the older generation (58% aged >70 years), whilst over one third (38%) occur in middle-aged adults.

Risk of TIA and stroke are increased in the older population, both age and frailty negatively impacting on outcomes. However, the influence of frailty on stroke outcomes (including physical function and cognition) is not well understood. Second, the association between death from cardiovascular disease (including stroke) and health inequality is also
stark with greater inequality associated with worse outcomes from heart attacks and strokes. It is therefore important to understand how diversity and inequality across the region relate specifically to mini-strokes (transient ischaemic attack, TIA) and strokes.

We therefore plan to identify patients assessed through the rapid access TIA clinics and stroke units in the East Midlands with the aim to explore the relationships between frailty, co-morbidity, health inequality and clinical outcomes. This information will help inform future trial design in the frail elderly population with stroke, and enable us to tailor more appropriate, potentially cost saving approaches to treatment.

Who can participate?
Patients aged over 40 years, who have had a stroke in the past 3 years

What does the study involve?
The study simply collects information through administration of a questionnaire at two time points (baseline and 90 days later) in two groups (within 6 weeks of the TIA/stroke; and >6 weeks of the TIA/stroke). The questionnaire at baseline is administered either face-to-face whilst in hospital, or sent via the post if the participant is at home. The questions asked 90 days later will be performed over the telephone.

What are the possible benefits and risks of participating?
None

Where is the study run from?
University of Nottingham (UK)

When is the study starting and how long is it expected to run for?
November 2019 to December 2021

Who is funding the study?
National Institute for Health Research CRN East Midlands (UK)

Who is the main contact?
Dr Tim England, timothy.england@nottingham.ac.uk
Diane Harvard, diane.havard@nottingham.ac.uk

Contact information

Dr Tim England
Scientific

Stroke Trials Unit
Division of Mental Health and Clinical Neuroscience
School of Medicine
Faculty of Medicine & Health Sciences
University of Nottingham
Royal Derby Hospital Centre
Uttoxeter Road
Derby
DE22 3DT
United Kingdom

ORCID ID	0000-0001-5330-8584
Phone	+44 (0)1332 724668
Email	timothy.england@nottingham.ac.uk

Mrs Diane Havard
Public

Stroke Trials Unit
Queen's Medical Centre
University of Nottingham
Nottingham
NG7 2UH
United Kingdom

Phone	+44 (0)115 8231775
Email	diane.havard@nottingham.ac.uk

Study information

Primary study design	Observational
Study design	Multi-centre pilot prospective population based longitudinal cohort study
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	Frailty, Inequality and Co-morbidity: a cohort study in TIA and Stroke
Study acronym	FINE-ST
Study objectives	Frailty, co-morbidity and health inequality negatively impact stroke outcomes. Understanding the relationship between frailty, multi-morbidity, inequality and outcome will inform the design of trials for current and future health care interventions in an ageing stroke population.
Ethics approval(s)	Approved 18/03/2020, HRA and Health and Care Research Wales (HCRW) (Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, UK; +44 (0)2920 785738; Wales.REC1@wales.nhs.uk), ref: 20/WA/0039
Health condition(s) or problem(s) studied	To initiate a stroke cohort to inform the relationship between frailty, multi-morbidity, socioeconomic status and clinical outcome in TIA and stroke.
Intervention	The study simply collects information through administration of a questionnaire at two time points (baseline and 90 days later) in two groups (within 6 weeks of the TIA/stroke; and >6 weeks of the TIA/stroke). The questionnaire at baseline is administered either face-to-face whilst in hospital, or sent via the post if the participant is at home. The questions asked 90 days later will be performed over the telephone.
Intervention type	Other
Primary outcome measure(s)	1. Frailty will be measured using the CFS, PRISMA 7 and FI-GCA at baseline and day 90. 2. Functional outcome will be measured using the MRS at baseline and day 90.
Key secondary outcome measure(s)	1. Frailty will be measured using the CFS, PRISMA 7 and FI-GCA at baseline and day 90. 2. Disability will be measured using the Barthel Index (BI) at baseline and day 90. 3. Dysphagia will be measured using the Dysphagia Severity Rating Scale (DSRS) at baseline and day 90 4. Cognition will be measured using the Montreal Cognitive Assessment (MoCA) and Telephone Mini Mental State Examination (t-MMSE) at baseline and day 90 5. Mood will be measured using the Geriatric Depression Scale (GDS) and Zung Depression Scale (ZDS) at baseline and day 90. 6. Inequality will be measured using the English Indices of Deprivation scale at baseline and day 90. 7. Fatigue will be measured using the Fatigue Assessment Scale (FAS) at baseline and day 90. 8. Co-morbidity will be measured using the Charleston Co-morbidity Index (CCI) at baseline.
Completion date	31/12/2021

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	200
Key inclusion criteria	1. TIA, ischaemic or haemorrhagic stroke in the last: 6 weeks (subacute group), or 6 weeks to 3 years (chronic group) 2. Age >40 years 3. Written consent from participant or proxy
Key exclusion criteria	1. Probable stroke mimic (e.g. migraine, functional neurology, brain tumour) 2. Life expectancy <3 months 3. Not expected to complete follow up at day 90 (e.g. homeless, out-of-area) 4. Level of consciousness prohibits engagement in baseline measures
Date of first enrolment	17/09/2020
Date of final enrolment	31/12/2021

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

Royal Derby Hospital

University Hospitals of Derby and Burton NHS Foundation Trust
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Nottingham City Hospital

Nottingham University Hospitals NHS Trust Stroke Services
Hucknall Road
Nottingham
NG5 1PB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
IPD sharing plan	All data generated or analysed during this study will be included in the subsequent results publication.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version 1.0	28/11/2019	09/09/2021	No	No

Additional files

40092 PROTOCOL v1.0 28Nov2019.docx: Protocol file

Editorial Notes

09/09/2021: Trial's existence confirmed by NHS HRA.