Acute StrokeEASYNCT04157231
Essential Acute Stroke Care in Low Resource Settings: a Pilot studY
A study testing Acute stroke care Intervention arm in people with Acute Stroke, run by The George Institute at 4 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Acute stroke care Intervention arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 30 Dec 2027to 30 Dec 2030
- Phase
- Interventional
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Rebecca Anderson contact
4 sites in 2 countries
Nigeria2 sites
Murtala Muhammad Specialist Hospital
Kano, Kano State, 3200
Federal Medical Centre
Lokoja, Kogi State, 1001
Dr Babatunde Ademiluyi, Dr
Peru2 sites
Hospital de Apoyo II-2 Sullana
Piura, Piura
Alan Gutierrez Nuñez, Dr
Hospital de la Amistad Peru Corea Santa Rosa II-2
Piura, Piura
Genaro Ipanaqué Chiroque, Dr
About this study
Official title: Essential Acute Stroke Care in Low Resource Settings: a Pilot Study
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
Read the 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.
- Conditions
- Acute Stroke
- Being tested
- Acute stroke care Intervention arm
- Keywords
- Stroke, Ischemic stroke, hemorrhagic stroke, stroke package
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute stroke care Intervention armOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Usual care to be provided to patients as per hospital guidelines for 3 months |
| Intervention arm | Other | The intervention consists of 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. This intervention will run for 3 months.
Refresher training will be given monthly during the intervention. Receives: Other: Acute stroke care Intervention arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
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.
Measured: 30 days
Secondary outcomes (1)
Death or disability
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).
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start30 Dec 2027 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The George Institute
- Sponsor type
- University, hospital or other
- Collaborators
- World Heart Federation
- Responsible party
- Sponsor
- Investigators
- Carlos Abanto, Dr, Principal investigator, National Institute of Neurological Sciences, Lima, PeruKolawawole Wahab, Professor, Principal investigator, University of Ilorin & University of Ilorin Teaching Hospital Ilorin, NigeriaHasan Farhan, Professor, Principal investigator, President of Iraqi Scientific Council of Cardiology,IraqYi Sui, Dr, Principal investigator, Shenyang First People's Hospital Hospital Affiliated Brain HospitalSaima Hilal, A/Professor, Principal investigator, National University of SingaporeLily Song, Dr, Principal investigator, The George Institute of Global Health, ChinaCraig Anderson, Professor, Principal investigator, Executive Director The George Institute for Global Health - China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157231
- Sponsor's protocol ID
- GI_NM-01-2019
- Acronym
- EASY
- Status last verified
- Dec 2025
- First submitted
- 4 Nov 2019
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Requests for access to the de-identified data that underlie the study results should be made to: datasharing@georgeinstitute.org. We will provide data to researchers with a methodologically sound proposal, and will work with interested parties to define and operationalise a data access agreement.