MORbidity PRevalence Estimate In StrokE

Stroke Clinical Trial

— MORe PREcISE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03605381
• Other study ID #: SP06
• Secondary ID: 03 ABUHB
• Status: Recruiting
• Start date: September 30, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: July 2019
• Source: Aneurin Bevan University Health Board
• Contact: Alexander Smith, BSc-MA-MRCOT
• Phone: +44(0)1633 238729
• Email: alexander.smith2[@]wales.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 30, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Aphasia
• Cerebral Hemorrhage
• Cerebral Infarction
• Cognitive Dysfunction
• CVA (Cerebrovascular Accident)
• CVA; Sequelae
• Depression
• Dysarthria
• Dysphagia
• Hemianopia
• Hemianopsia
• Hemiparesis
• Hemiplegia
• Hemispatial Neglect
• Hemorrhage
• Infarction
• Intracerebral Hemorrhage
• Mild Cognitive Impairment
• Paresis
• Perceptual Disorders
• Stroke
• Stroke Hemorrhagic
• Stroke, Ischemic

Locations

Country	Name	City	State
United Kingdom	Prince Charles Hospital	Merthyr Tydfil
United Kingdom	Royal Gwent Hospital	Newport	Gwent
United Kingdom	Ysbyty Ystrad Fawr	Ystrad Mynach	Caerphilly

Sponsors (1)

Lead Sponsor	Collaborator
Aneurin Bevan University Health Board

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity Secondary to Stroke	The primary aim of this study is to quantify the prevalence of morbidity at six months post-stroke, measured using a PROM	6 months post-stroke