MORbidity PRevalence Estimate In StrokE (MORe PREcISE)

July 2, 2019 updated by: Dr Jonathan Hewitt, Aneurin Bevan University Health Board

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.

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 Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Merthyr Tydfil, United Kingdom, CF47 9DT
        • Recruiting
        • Prince Charles Hospital
        • Contact:
        • Principal Investigator:
          • Kerry Morgan, DipN, MSc
    • Caerphilly
      • Ystrad Mynach, Caerphilly, United Kingdom, CF82 7EP
        • Recruiting
        • Ysbyty Ystrad Fawr
        • Contact:
        • Principal Investigator:
          • Jonathan Hewitt, MBBS, FRCP (Glas), MSc, PhD
    • Gwent
      • Newport, Gwent, United Kingdom, NP20 2UB
        • Recruiting
        • Royal Gwent Hospital
        • Contact:
        • Principal Investigator:
          • Kylie Crook, DipN, PgDip, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Stroke survivors admitted to stroke units across the UK

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months post-stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aneurin Bevan University Health Board

Investigators

  • Principal Investigator: Jonathan Hewitt, MBBS, PhD, Cardiff University & Aneurin Bevan University Health Board

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2018

Primary Completion (Anticipated)

August 31, 2019

Study Completion (Anticipated)

September 30, 2019

Study Registration Dates

First Submitted

July 20, 2018

First Submitted That Met QC Criteria

July 20, 2018

First Posted (Actual)

July 30, 2018

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 2, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP06
  • 03 ABUHB (Other Grant/Funding Number: Stroke Implementation Group (Wales))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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