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Clinical Trials/NCT03605381
NCT03605381
Unknown
Not Applicable

Morbidity Prevalence Estimate at Six Months Following a Stroke: A Cohort Study.

Aneurin Bevan University Health Board3 sites in 1 country500 target enrollmentSeptember 30, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Aneurin Bevan University Health Board
Enrollment
500
Locations
3
Primary Endpoint
Morbidity Secondary to Stroke
Last Updated
6 years ago

Overview

Brief Summary

Information regarding the likely progress of post-stroke symptoms is vitally important to stroke survivors to allow them to plan for the future and to adjust to life after stroke. Moreover, the prevalence of morbidity secondary to stroke is of central importance to Health Professionals to understand the prognosis of the disease in the patients under their care. Additionally, it will also allow commissioners of care, planners and third sector organisations to adapt to and answer the needs of a post-stroke population.

Currently, the data collected by national audit programmes are concentrated on what can be termed 'process or process of care' data. The utility of these data are in the ability to audit the care received by stroke survivors on stroke units against evidenced standards for care, thus ensuring evidence based practice. Nevertheless, process of care is only one form of measuring stroke unit care and the audit programmes collect some limited functional status data, data relating to risk-factor co-morbidities and treatment received data. Therefore, the scope of this study is to build on the minimum data set currently collected and to collect post-stroke data in domains not currently collected.

The International Consortium for Health Outcomes Measurement (ICHOM) takes important steps to collect data outside of process of care data such as a Patient Reported outcome data in their minimum outcome data set for stroke [currently under review].. Nevertheless, the ICHOM doesn't currently advocate the specific collection of data relating to cognitive impairment or emotional problems secondary to stroke. It is in these important aspects that this study will augment the data set currently advocated by ICHOM to collect data in the areas of cognitive impairment and emotional problems secondary to stroke.

Therefore, the aim of this study is to quantify the prevalence of morbidity at six months post-stroke.

Registry
clinicaltrials.gov
Start Date
September 30, 2018
End Date
September 30, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr Jonathan Hewitt

Clinical Senior Lecturer & Honorary Consultant Physician

Aneurin Bevan University Health Board

Eligibility Criteria

Inclusion Criteria

  • Clinically confirmed diagnosis of stroke either;
  • Cerebral Infarct (ICD I63) \[1\]
  • Intracerebral Haemorrhage (ICD I61) \[1\]
  • Stroke, not specified as haemorrhage or infarction (ICD I64) \[1\]
  • 18 years of age or older (≥ 18 years old)
  • Received a clinically confirmed diagnosis of stroke within the previous 14 days (Stroke diagnosis ≤ 14 days)

Exclusion Criteria

  • Clinically confirmed diagnosis of any of the following
  • Transient Ischaemic Attack (ICD G45) \[1\]
  • Subarachnoid Haemorrhage (ICD I60) \[1\]
  • Any condition defined under ICD G93 e.g. Anoxic brain damage \[1\]
  • Patients receiving or eligible for Palliative Care.

Outcomes

Primary Outcomes

Morbidity Secondary to Stroke

Time Frame: 6 months post-stroke

The primary aim of this study is to quantify the prevalence of morbidity at six months post-stroke, measured using a PROM

Study Sites (3)

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