Clinical trial NCT03605381: MORbidity PRevalence Estimate In StrokE
Official title: Morbidity Prevalence Estimate at Six Months Following a Stroke: A Cohort Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
CVA (Cerebrovascular Accident)
CVA; Sequelae
Stroke, Ischemic
Stroke Hemorrhagic
Hemianopia
Hemiplegia
Hemiparesis
Aphasia
Cerebral Infarction
Intracerebral Hemorrhage
Anxiety
Depression
Dysphagia
Dysarthria
Hemispatial Neglect
Mild Cognitive Impairment
Keywords: Stroke
PROMs
Cohort
Lead sponsor: Aneurin Bevan University Health Board
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke survivors admitted to stroke units across the UK

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.


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.

Primary outcomes:
measure: Morbidity Secondary to Stroke
timeFrame: 6 months post-stroke
Secondary outcomes:
Other outcomes:
Locations:
city: Ystrad Mynach
country: United Kingdom
facility: Ysbyty Ystrad Fawr
state: Caerphilly
city: Newport
country: United Kingdom
facility: Royal Gwent Hospital
state: Gwent
city: Merthyr Tydfil
country: United Kingdom
facility: Prince Charles Hospital
Study officials:
affiliation: Cardiff University & Aneurin Bevan University Health Board
name: Jonathan Hewitt, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith A, Bains N, Copeland L, Pennington A, Carter B, Hewitt J. Morbidity Prevalence Estimate at 6 Months Following a Stroke: Protocol for a Cohort Study. JMIR Res Protoc. 2020 Jun 17;9(6):e15851. doi: 10.2196/15851.