Acute Stroke
Conditions
Keywords
Stroke, Ischemic stroke, hemorrhagic stroke, stroke package
Brief summary
An investigator-initiated, evaluator-blinded, prospective, multi centre, before-and-after, effectiveness-implementation hybrid design study to assess the feasibility of essential acute stroke care in a low resource setting
Detailed description
This is a multicentre, before and after, effectiveness-implementation hybrid study design with blinded outcome assessment. Patients admitted to the participating hospitals will be managed under usual care conditions for three months (control arm). This will be followed by the training of the doctors and nurses in those hospitals on essential acute stroke care management. Patient management for the following three months after the training (intervention) will then be assessed to evaluate its impact on the care and clinical outcome of the patients.
Interventions
OTHERAcute stroke care Intervention arm
Training and education of the site staff about the treatment protocol for the different components of the management plan will be provided on two occasions. The aim of these sessions will be to educate stroke champions and other site staff on the management protocols. Available training resources will be accessed (including online materials) and simulation training will be used. New skills such as dysphagia assessment will be emphasized based on existing knowledge and competencies. After training, staff will have another assessment (Post-test) in order to determine whether they have been adequately trained and are able to adhere to the essential acute stroke care management plan. A standardised Power Point presentation and accompanying handouts will be made available for further use in the ward. Refresher training will be provided monthly during the intervention.
Sponsors
The George Institute
World Heart Federation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
The clinical outcome will be assessed by a blinded assessor
Intervention model description
A before and after, effectiveness-implementation hybrid study design with blinded outcome assessment will be conducted. This type 1 effectiveness-implementation hybrid design will test the essential acute stroke care management plan and secondarily gather data to inform subsequent research trials
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (age ≥18 years) * A clinical or imaging-based diagnosis of acute stroke (ischemic or haemorrhagic) within 72 hours of stroke symptom onset * Provision of written informed consent * Subjects in observational, natural history and/or epidemiological studies not involving an intervention are eligible.
Exclusion criteria
* Patients who have undergone intravenous thrombolysis or mechanical thrombectomy * Patients who are planned for transfer to the intensive care unit * Subarachnoid haemorrhage * Participation in an interventional medical investigation or clinical trial currently or within the past 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence | 30 days | Primary Outcome Measure: Adherence to the predefined components of the essential acute stroke care management plan Adherence will be expressed as all or none measure and is defined as the proportion of patients who receive all the components of acute stroke care management for which the patient is eligible. Adherence will also be expressed as a composite measure, which is defined as the total number of eligible components performed divided by the total number of components for which the patient was eligible. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death or disability | 30 Days | Death or disability as measured by Modified Rankin Scale (mRS) at 30 days. The mRS is a disability scale that ranges from 0 (no symptoms) to 6 (death). |
Countries
Nigeria, Peru
Contacts
CONTACTCheryl Carcel, Dr
CONTACTRebecca Anderson
PRINCIPAL_INVESTIGATORCarlos Abanto, Dr
National Institute of Neurological Sciences, Lima, Peru
PRINCIPAL_INVESTIGATORKolawawole Wahab, Professor
University of Ilorin & University of Ilorin Teaching Hospital Ilorin, Nigeria
PRINCIPAL_INVESTIGATORHasan Farhan, Professor
President of Iraqi Scientific Council of Cardiology,Iraq
PRINCIPAL_INVESTIGATORYi Sui, Dr
Shenyang First People's Hospital Hospital Affiliated Brain Hospital
PRINCIPAL_INVESTIGATORSaima Hilal, A/Professor
National University of Singapore
PRINCIPAL_INVESTIGATORLily Song, Dr
The George Institute of Global Health, China
PRINCIPAL_INVESTIGATORCraig Anderson, Professor
Executive Director The George Institute for Global Health - China
Outcome results
None listed