StrokeMORe PREcISENCT03605381
MORbidity PRevalence Estimate In StrokE
An observational study of Stroke and CVA (Cerebrovascular Accident), run by Aneurin Bevan University Health Board at 3 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, CVA (Cerebrovascular Accident), CVA; Sequelae
- How many people
- 500 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 30 Sep 2018to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke survivors admitted to stroke units across the UK
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 3 recruiting
- Recruiting
Prince Charles Hospital
Merthyr Tydfil, CF47 9DT
Kerry Morgan, DipN, MSc, +44 (0)1443 430022, Kerry.Morgan@wales.nhs.uk
Kerry Morgan, DipN, MSc
- Recruiting
Royal Gwent Hospital
Newport, Gwent, NP20 2UB
Kylie Crook, DipN, PgDip, MSc, +44 (0)1633 234868, Kylie.Crook@wales.nhs.uk
Kylie Crook, DipN, PgDip, MSc
- Recruiting
Ysbyty Ystrad Fawr
Ystrad Mynach, Caerphilly, CF82 7EP
Alexander Smith, BSc, MA, +44 (0)1495 765121, alexander.smith2@wales.nhs.uk
Jonathan Hewitt, MBBS, FRCP (Glas), MSc, PhD
About this study
Official title: Morbidity Prevalence Estimate at Six Months Following a Stroke: A Cohort Study.
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.
Read more
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
- Keywords
- Stroke, PROMs, Cohort
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic Stroke, Hemianopsia, Hemiplegia, Paresis, Aphasia, Cerebral Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months post-stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start30 Sep 2018
- Primary completion31 Aug 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aneurin Bevan University Health Board
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jonathan Hewitt, Aneurin Bevan University Health Board
- Investigators
- Jonathan Hewitt, MBBS, PhD, Principal investigator, Cardiff University & Aneurin Bevan University Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605381
- Sponsor's protocol ID
- SP06
- Other IDs
- 03 ABUHB
- Acronym
- MORe PREcISE
- Status last verified
- Jul 2019
- First submitted
- 20 Jul 2018
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morbidity Prevalence Estimate at Six Months Following a Stroke: A Cohort Study.
- ClinicalTrials.gov ID
- NCT03605381
- Acronym / sponsor ID
- MORe PREcISE / SP06
- Conditions
- Stroke, CVA (Cerebrovascular Accident), CVA; Sequelae, Stroke, Ischemic, Stroke Hemorrhagic, Hemianopia
- Keywords
- Stroke, PROMs, Cohort
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Aneurin Bevan University Health BoardUniversity, hospital or other
- Study start
- 30 Sep 2018 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 30 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke survivors admitted to stroke units across the UK
Key inclusion criteria (6 listed)
- Clinically confirmed diagnosis of stroke either;
- 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)
Key exclusion criteria (5 listed)
- Clinically confirmed diagnosis of any of the following
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Morbidity Secondary to Stroke
Time frame: 6 months post-stroke
The primary aim of this study is to quantify the prevalence of morbidity at six months post-stroke, measured using a PROM
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Derived from this study: PubMed 32512539Smith 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Hewitt, MBBS, PhD principal investigator
Cardiff University & Aneurin Bevan University Health Board
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and CVA (Cerebrovascular Accident), run by Aneurin Bevan University Health Board at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Smith, BSc-MA-MRCOT (+44(0)1633 238729, alexander.smith2@wales.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity Secondary to Stroke (time frame: 6 months post-stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03605381, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.