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临床试验/NCT05298436
NCT05298436招募中不适用

The South London Stroke Register: Improving the Lives of Stroke Survivors With Data

Guy's and St Thomas' NHS Foundation Trust7 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,000
试验地点
7
主要终点
Stroke incidence

研究概览

简要总结

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

详细描述

The South London Stroke Register is a long-running population-based stroke register including all patients with first stroke occuring in a defined area of London. 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.

Notification for SLSR has been ongoing since 1st January 1995 and uses multiple overlapping sources of notification, but more recently focussing on notification sources in hospitals, in line with the evolution and reorganisation of the stroke care pathway. Since the centralisation of London stroke services in 2010, all suspected stroke patients are taken by ambulance to one of 8 hyper acute stroke units. These units provide 24/7 access to specialist care and evidence based treatment to admitted patients. Notification sources for the new data collection will include these hyper acute stroke units, stroke units, outpatient stroke clinics, radiology and other relevant wards. Stroke patients presenting anywhere in the health service including A&E departments or GP surgeries should be identifiable from these sources.

The study will use 8 hospital centres: Primary sites at St Thomas' and King's College Hospitals and secondary sites at St George's, Charing Cross, Royal London, Princess Royal University, University College London, and Chelsea and Westminster hospitals. Primary sites are hospitals within the boundaries of the study area. According to the current service organisation they should receive all patients resident within the study area. King's College Hospital has both a hyper acute stroke unit and a stroke unit, while St Thomas' has a stoke unit only. Both sites have run 'Transient Ischaemic Attack (TIA) clinic', which is an acute/urgent referral service largely from A+E and primary care for the assessment of people with transient neurological symptoms or late presentation of stroke. These units and clinics will serve as primary notification sources. Patients living near the boundaries of the study area may be admitted to hospitals outside the district and the ambulance system may occasionally take patients to outlying hospitals. These patients will normally be repatriated to the stroke units at their local hospitals (the primary sites) and in many cases could be notified from there. The inclusion of relevant hospitals as secondary sites will ensure capture of the few cases who will be discharged home directly rather than repatriated.

Study teams will visit the hyper acute stroke unit at King's College Hospital and the stroke units at both hospitals and review electronic patient records daily during the working week. Outpatient stroke clinics take place twice weekly at both hospitals. Study teams will visit the clinics and screen patient records to identify mild stroke patients (including those formerly classed as TIAs) not captured at the hyper acute unit and stroke units. This will be a key site for notification of lower risk events, which are not typically referred to stroke units.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Stroke incidence

时间窗: April 2022 - December 2026

Stroke incidence in a geographically defined area of South London

Stroke mortality

时间窗: April 2022 - December 2026

All-cause mortality rate post-stroke

12-Item Short Form Survey (SF-12)

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

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

EuroQuol-5D-5L, EQ-5D-5L

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

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)

modified Rankin Scale, mRS

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

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

Abbreviated Mental Test, AMT-10

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

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

Hospital Anxiety and Depression Scale

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

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

Barthel Index

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

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

Frenchay Activities Index

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

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

Montreal Cognitive Assessment, MoCA

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

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

Stroke recurrence

时间窗: April 2022 - December 2026

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (7)

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