MORbidity PRevalence Estimate In StrokE

NCT03605381 | Unknown DMC

• 2 other identifiers: SP0603 ABUHB
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stroke survivors admitted to stroke units across the UK

You may qualify if:

• 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) \[1\]
• years of age or older (≥ 18 years old)
• Received a clinically confirmed diagnosis of stroke within the previous 14 days (Stroke diagnosis ≤ 14 days)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aneurin Bevan University Health Board: lead

Study Sites (3)

Ysbyty Ystrad Fawr

Ystrad Mynach, Caerphilly, CF82 7EP, United Kingdom

RECRUITING

Royal Gwent Hospital

Newport, Gwent, NP20 2UB, United Kingdom

RECRUITING

Prince Charles Hospital

Merthyr Tydfil, CF47 9DT, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 32512539 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke; Hemianopsia; Hemiplegia; Paresis; Aphasia; Cerebral Infarction; Cerebral Hemorrhage; Anxiety Disorders; Depression; Deglutition Disorders; Dysarthria; Perceptual Disorders; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Blindness; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Brain Infarction; Brain Ischemia; Infarction; Ischemia; Pathologic Processes; Necrosis; Intracranial Hemorrhages; Hemorrhage; Mental Disorders; Behavioral Symptoms; Behavior; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Articulation Disorders; Cognition Disorders; Neurocognitive Disorders

Study Officials

• Jonathan Hewitt, MBBS, PhD

  Cardiff University & Aneurin Bevan University Health Board

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Smith, BSc-MA-MRCOT

CONTACT

+44(0)1633 238729; alexander.smith2@wales.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Senior Lecturer & Honorary Consultant Physician

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: July 30, 2018
• Study Start: September 30, 2018
• Primary Completion: August 31, 2019
• Study Completion: September 30, 2019
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

GB (3)