MORbidity PRevalence Estimate In StrokE

NCT ID: NCT03605381

Last Updated: 2019-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-30

Study Completion Date

2019-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aneurin Bevan University Health Board

OTHER

Sponsor Role lead

Responsible Party

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Dr Jonathan Hewitt

Clinical Senior Lecturer & Honorary Consultant Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jonathan Hewitt, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

Cardiff University & Aneurin Bevan University Health Board

Locations

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Ysbyty Ystrad Fawr

Ystrad Mynach, Caerphilly, United Kingdom

Site Status RECRUITING

Royal Gwent Hospital

Newport, Gwent, United Kingdom

Site Status RECRUITING

Prince Charles Hospital

Merthyr Tydfil, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Alexander Smith, BSc-MA-MRCOT

Role: CONTACT

+44(0)1633 238729

Facility Contacts

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Alexander Smith, BSc, MA

Role: primary

+44 (0)1495 765121

Kylie Crook, DipN, PgDip, MSc

Role: primary

+44 (0)1633 234868

Kerry Morgan, DipN, MSc

Role: primary

+44 (0)1443 430022

References

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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.

Reference Type DERIVED
PMID: 32512539 (View on PubMed)

Other Identifiers

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03 ABUHB

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SP06

Identifier Type: -

Identifier Source: org_study_id

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