FINE-ST: Frailty and inequality in stroke
| ISRCTN | ISRCTN11241011 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11241011 |
| IRAS number | 273619 |
| Secondary identifying numbers | IRAS 273619, CPMS 44689 |
- 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
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
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 |
| timothy.england@nottingham.ac.uk |
Public
Stroke Trials Unit
Queen's Medical Centre
University of Nottingham
Nottingham
NG7 2UH
United Kingdom
| Phone | +44 (0)115 8231775 |
|---|---|
| diane.havard@nottingham.ac.uk |
Study information
| Study design | Multi-centre pilot prospective population based longitudinal cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a 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 | 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. |
| Secondary outcome measures | 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. |
| Overall study start date | 28/11/2019 |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centres
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Sponsor information
University/education
Research and Innovation
University of Nottingham
East Atrium
Jubilee Conference Centre
Triumph Road
Nottingham
NG7 2RD
England
United Kingdom
| Phone | +44 (0)1158467906 |
|---|---|
| sponsor@nottingham.ac.uk | |
| Website | http://www.nottingham.ac.uk/ |
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| 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? |
|---|---|---|---|---|---|
| Protocol file | version 1.0 | 28/11/2019 | 09/09/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
09/09/2021: Trial's existence confirmed by NHS HRA.
