The South London Stroke Register: Improving the Lives of Stroke Survivors With Data
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGuy's and St Thomas' NHS Foundation Trust
About this trial
The South London Stroke Register (SLSR) is an observational population based registry, combining a population incidence study of stroke events in a geographically defined area of South London and a cohort study of these patients followed up over time. The SLSR has been continually ongoing since January 1995 using the WHO ICD-10 definition of stroke. From April 2022, SLSR will use the new ICD-11 definition for case identification to establish a new prospective cohort of patients identified according to the new definition.
Follow up of the existing retrospective cohort of current patients will continue, providing data on long term outcomes of stroke through a program of regular patient interviews up to 15 years after stroke. Outcome measures include health outcomes, such as stroke mortality and recurrence, and measures of activities of daily living, quality of life and mental health (cognition, anxiety, depression).
The new data collection will include newly selected scales to best capture variation in key health domains and long term outcomes.
The change to ICD-11 is expected to lead to an increase in the incidence of stroke and a reduction in the average severity, but the effects of this change have not yet been measured in any population internationally. There is a need for a high quality population-based stroke incidence study to address this gap. Similarly, the factors determining the health of long-term stroke survivors can only be understood using a long running observational cohort study.
The overall purpose of this research is to continue and develop the SLSR data collection and analysis to address the needs of stroke patients in the 2020s. The current programme was funded to address the following objectives as part of a broader NIHR programme grant on using data to improve the lives of stroke survivors:
* Understand the impact of the ICD-11 new definition of stroke * Define the outcomes and needs of long-term stroke survivors * Support stroke survivors and stakeholders with these detailed data and analyses * Describe the use of formal, informal, and social care services up to 15 years after stroke * Asses the influence of formal, informal, and social care use on stroke recovery and generate patient-level total costs up to 15 years after stroke
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmed stroke (WHO ICD-11 clinical definition)- cerebral ischaemic stroke, primary intracerebral haemorrhage, subarachnoid haemorrhage and stroke not known if ischaemic or haemorrhagic. Formerly defined Transient Ischaemic Attacks with CT/MRI evidence of cerebrovascular disease are classified as stroke under this definition.
Living in the study area at the time of the first stroke.
First stroke since 1st January 1995 for enrolled participants. First stroke since 1st April 2022 for updated definition.
Disqualifiers
First ever stroke is before 1st January 1995
Patients' main residence at the time of first stroke is outside the study area.
Focal neurological signs resolved within 24 hours and no CT/MRI scan reports evidence of cerebrovascular disease (i.e. transient ischaemic attack)
CT/MRI scans positive for cerebrovascular disease but absence of related focal neurological deficits (asymptomatic cerebrovascular disease)
Trial population
The study area comprises 27 electoral wards in the Northern part of Lambeth and Southwark and participant's residence within these wards is confirmed by postcode. Information on the population denominator, including sociodemographic details of the catchment area, is obtained through the ONS. The study area comprises a multi-ethnic population of 357,308, of whom about 56% are white, 25% black, 6% Asian and 12% other ethnic groups (according to 2011 population census)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Follow-up interview
Other interventionAll participants will be followed up at defined time points post-stroke by face-to-face or telephone interview or postal questionnaire.
Treatment groups
2,000 Participants
are divided into 2 treatment groupsGroup A: Retrospective Cohort (ICD-10)1 intervention
Group B: Prospective Cohort (ICD-11)1 intervention
Trial outcomes
Primary outcomes
1
Stroke incidence
Stroke incidence in a geographically defined area of South London
Time frame
April 2022 - December 20262
Stroke mortality
All-cause mortality rate post-stroke
Time frame
April 2022 - December 20263
Stroke recurrence
Stroke occurring at least 21 days after index stroke or in different anatomical territory
Time frame
April 2022 - December 20264
Barthel Index
10-item scale to measure performance in activities of daily living ADL, score 0 - 100, 100=most active
Time frame
acute phase, 3 months and up to 15 years post-stroke for the retrospective cohort and 5 years post-stroke for the prospective cohort.Sponsors and contacts
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Source ClinicalTrials.gov