CClinicalTrials.gg
Status unknownNCT03605381MORe PREcISEUpdated Jul 5, 2019

MORbidity PRevalence Estimate In StrokE

An observational study in Stroke, CVA (Cerebrovascular Accident) and CVA; Sequelae, sponsored by Aneurin Bevan University Health Board. Status unknown at 3 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-05.

Sponsored by Aneurin Bevan University Health Board · Observational

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Stroke survivors admitted to stroke units across the UK

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No
05

What researchers measure

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

    Time frame: 6 months post-stroke

06

Study locations

3 of 3 sites recruiting
  • Ysbyty Ystrad Fawr
    Ystrad Mynach, Caerphilly CF82 7EP, United Kingdom
    • Alexander Smith, BSc, MA · Contact · alexander.smith2@wales.nhs.uk · +44 (0)1495 765121
    • Jonathan Hewitt, MBBS, FRCP (Glas), MSc, PhD · Principal investigator
    Recruiting
  • Royal Gwent Hospital
    Newport, Gwent NP20 2UB, United Kingdom
    • Kylie Crook, DipN, PgDip, MSc · Contact · Kylie.Crook@wales.nhs.uk · +44 (0)1633 234868
    • Kylie Crook, DipN, PgDip, MSc · Principal investigator
    Recruiting
  • Prince Charles Hospital
    Merthyr Tydfil, CF47 9DT, United Kingdom
    • Kerry Morgan, DipN, MSc · Contact · Kerry.Morgan@wales.nhs.uk · +44 (0)1443 430022
    • Kerry Morgan, DipN, MSc · Principal investigator
    Recruiting
07

References and documents

Publications

  • 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. PubMed 32512539 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03605381
Lead sponsor
Aneurin Bevan University Health Board
Responsible party
Dr Jonathan Hewitt (Clinical Senior Lecturer & Honorary Consultant Physician, Aneurin Bevan University Health Board) — Principal investigator
First posted
Jul 30, 2018
Start date
Sep 30, 2018
Primary completion
Aug 31, 2019 (estimated)
Completion
Sep 30, 2019 (estimated)
Last update
Jul 5, 2019

Study contacts

Alexander Smith, BSc-MA-MRCOT
Contact
alexander.smith2@wales.nhs.uk
+44(0)1633 238729
Jonathan Hewitt, MBBS, PhD
principal investigator · Cardiff University & Aneurin Bevan University Health Board

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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