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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Essential Acute Stroke Care in Low Resource Settings: a Pilot Study
- ClinicalTrials.gov ID
- NCT04157231
- Acronym / sponsor ID
- EASY / GI_NM-01-2019
- Conditions
- Acute Stroke
- Keywords
- Stroke, Ischemic stroke, hemorrhagic stroke, stroke package
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The George InstituteUniversity, hospital or other
- Collaborators
- World Heart Federation
- Study start
- 30 Dec 2027 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 8 Nov 2019 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Usual care to be provided to patients as per hospital guidelines for 3 months |
| Intervention arm | Other | Other: Acute stroke care Intervention armThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute stroke care Intervention armTraining 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. | Other | Intervention arm |
Primary outcome
Adherence
Time frame: 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.
1 secondary outcome
Death or disability
Time frame: 30 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: 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.
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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.
Rebecca Anderson contact
Carlos Abanto, Dr principal investigator
National Institute of Neurological Sciences, Lima, Peru
Kolawawole Wahab, Professor principal investigator
University of Ilorin & University of Ilorin Teaching Hospital Ilorin, Nigeria
Hasan Farhan, Professor principal investigator
President of Iraqi Scientific Council of Cardiology,Iraq
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute stroke care Intervention arm in people with Acute Stroke, run by The George Institute at 4 sites in 2 countries.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Nigeria, Peru. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cheryl Carcel, Dr (+61 2 8052 4508, ccarcel@georgeinstitute.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2026.