ClinicalTrials.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has not verified this record recently (last verified Jul 2019), so the status shown — last known as Recruiting — may be out of date.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

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's planned enrollment of 500 is above the median of 152 across 1,968 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Aneurin Bevan University Health Board is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

    • (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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No
06

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

07

Study locations

3 of 3 sites recruiting
  • Ysbyty Ystrad Fawr
    Ystrad Mynach, Caerphilly CF82 7EP, United Kingdom
    Recruiting
    • Alexander Smith, BSc, MA · Contactalexander.smith2@wales.nhs.uk · +44 (0)1495 765121
    • Jonathan Hewitt, MBBS, FRCP (Glas), MSc, PhD · Principal investigator
  • Royal Gwent Hospital
    Newport, Gwent NP20 2UB, United Kingdom
    Recruiting
    • Kylie Crook, DipN, PgDip, MSc · ContactKylie.Crook@wales.nhs.uk · +44 (0)1633 234868
    • Kylie Crook, DipN, PgDip, MSc · Principal investigator
  • Prince Charles Hospital
    Merthyr Tydfil, CF47 9DT, United Kingdom
    Recruiting
    • Kerry Morgan, DipN, MSc · ContactKerry.Morgan@wales.nhs.uk · +44 (0)1443 430022
    • Kerry Morgan, DipN, MSc · Principal investigator
08

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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2018 (actual). Primary completion is estimated for Aug 2019, 11 months after the start.

Of 835 non-industry observational studies under Stroke, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 92. This study's planned 11 months is below that.

Counting every sponsor, half of 897 studies reached it within 40 months; a quarter within 18 and three quarters within 85.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 20, 2018
First posted
Jul 30, 2018
StartActual
Sep 30, 2018
Primary completionEst.
Aug 31, 2019
CompletionEst.
Sep 30, 2019
Last update
Jul 5, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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