NCT05298436

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Apr 2022

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Apr 2022Dec 2026

First Submitted

Initial submission to the registry

March 16, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 28, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

4.7 years

First QC Date

March 16, 2022

Last Update Submit

March 5, 2024

Conditions

Keywords

RegistriesEpidemiologyCohort study

Outcome Measures

Primary Outcomes (11)

  • Stroke incidence

    Stroke incidence in a geographically defined area of South London

    April 2022 - December 2026

  • Stroke mortality

    All-cause mortality rate post-stroke

    April 2022 - December 2026

  • Stroke recurrence

    Stroke occurring at least 21 days after index stroke or in different anatomical territory

    April 2022 - December 2026

  • Barthel Index

    10-item scale to measure performance in activities of daily living ADL, score 0 - 100, 100=most active

    acute phase, 3 months and up to 15 years post-stroke for the retrospective cohort and 5 years post-stroke for the prospective cohort.

  • Frenchay Activities Index

    15-item scale to measure performance in instrumental activities of daily living IADL, score 15 - 60, 60=most active

    3 months and up to 15 years post-stroke for the retrospective cohort and 5 years post-stroke for the prospective cohortr

  • modified Rankin Scale, mRS

    measure of degree of disability/dependence after stroke, score 0 - 5, 5 = most disabled

    acute phase, 3 months, and up to 15 years post-stroke for the retrospective cohort and 5 years post-stroke for the prospective cohort

  • Abbreviated Mental Test, AMT-10

    screening tool to identify cognitive impairment, score 0 - 10, 0=worse cognitive impairment

    acute phase, 3 months, and up to 15 years post-stroke for the retrospective cohort and 5 years post-stroke for the prospective cohort

  • Montreal Cognitive Assessment, MoCA

    screening tool to identify mild cognitive impairment, score 0 - 30, 0=worse cognitive impairment

    acute phase, 3 months, and up to 15 years post-stroke for the retrospective cohort and 5 years post-stroke for the prospective cohort

  • 12-Item Short Form Survey (SF-12)

    self-reported outcome measure to assess generic health outcomes from patient's perspective, score 0 - 100, higher scores = better physical/mental health

    3 months, and up to 15 years post-stroke for the retrospective cohort and 5 years post-stroke for the prospective cohort

  • Hospital Anxiety and Depression Scale

    14 item self-reported measure to assess anxiety and depression in medical patients, score 0 - 42, higher scores = worse anxiety/depression

    3 months, and up to 15 years post-stroke for the retrospective cohort and 5 years post-stroke for the prospective cohort

  • EuroQuol-5D-5L, EQ-5D-5L

    outcome measure to evaluate the generic quality of life in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), level 11111(full health) - 55555 (worst health)

    acute phase, 3 months, and up to 15 years post-stroke for the retrospective cohort and 5 years post-stroke for the prospective cohort

Study Arms (2)

Retrospective Cohort (ICD-10)

All participants with stroke according to WHO ICD-10 definition registered on the SLSR prior to the protocol change in April 2022 will be followed up by interview at 3 months, 1 year, and 5, 10 and 15 years after stroke.

Other: Follow-up interview

Prospective Cohort (ICD-11)

All participants with stroke according to WHO ICD-11 definition registered on the SLSR following the protocol change in April 2022 will be followed up by interview at 3 months and then annually up to 5 years.

Other: Follow-up interview

Interventions

All participants will be followed up at defined time points post-stroke by face-to-face or telephone interview or postal questionnaire.

Prospective Cohort (ICD-11)Retrospective Cohort (ICD-10)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)
  • brain lesion other than stroke causes the acute symptoms such as cerebral tumour or metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Barts Health NHS Trust

London, E1 2ES, United Kingdom

RECRUITING

University College London hospitals NHS Foundation trust

London, NW1 2PG, United Kingdom

NOT YET RECRUITING

Guy's and St Thomas' NHS Foundation trust

London, SE1 7EH, United Kingdom

RECRUITING

King's College hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

RECRUITING

Chelsea and Westminster Hospital NHS Foundation Trust

London, Sw10 9NH, United Kingdom

NOT YET RECRUITING

St George's University Hospitals NHS Foundation Trust

London, SW17 0QT, United Kingdom

RECRUITING

Imperial College Healthcare NHS trust

London, W2 1BL, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

StrokeSubarachnoid HemorrhageIntracranial Hemorrhages

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Iain Marshall

    King's College London, UK

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
15 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2022

First Posted

March 28, 2022

Study Start

April 1, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 6, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations