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Not yet recruitingNCT04157231EASYUpdated Jun 11, 2026

Essential Acute Stroke Care in Low Resource Settings: a Pilot studY

An interventional study of Acute stroke care Intervention arm in Acute Stroke, sponsored by The George Institute. Not yet recruiting at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.

Sponsored by The George Institute · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Acute Stroke

Keywords

  • Stroke
  • Ischemic stroke
  • hemorrhagic stroke
  • stroke package
03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's planned enrollment of 300 is above the median of 49 across 6,024 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

The George Institute is the lead sponsor of 57 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • Subjects in observational, natural history and/or epidemiological studies not involving an intervention are eligible.

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
Single (Outcomes assessor)
Enrollment
300 participants (estimated)

Study arms

  • No intervention
    Usual Care

    Usual care to be provided to patients as per hospital guidelines for 3 months

  • Other
    Intervention arm

    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.

    Other: Acute stroke care Intervention arm

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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).

    Time frame: 30 Days

07

Study locations

4 sites
  • Murtala Muhammad Specialist Hospital
    Kano, Kano State 3200, Nigeria
  • Federal Medical Centre
    Lokoja, Kogi State 1001, Nigeria
    • Dr Babatunde Ademiluyi, Dr · Contact
  • Hospital de Apoyo II-2 Sullana
    Piura, Piura, Peru
    • Alan Gutierrez Nuñez, Dr · Principal investigator
  • Hospital de la Amistad Peru Corea Santa Rosa II-2
    Piura, Piura, Peru
    • Genaro Ipanaqué Chiroque, Dr · Principal investigator
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: Data will be available after publication of the main paper

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04157231
Lead sponsor
The George Institute
Collaborators
World Heart Federation
Responsible party
Sponsor
First posted
Nov 8, 2019
Start date
Dec 30, 2027 (estimated)
Primary completion
Jun 30, 2030 (estimated)
Completion
Dec 30, 2030 (estimated)
Last update
Jun 11, 2026

Study contacts

Cheryl Carcel, Dr
Contact
ccarcel@georgeinstitute.org.au
+61 2 8052 4508
Rebecca Anderson
Contact
randerson@georgeinstitute.org.au
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
Yi Sui, Dr
principal investigator · Shenyang First People's Hospital Hospital Affiliated Brain Hospital
Saima Hilal, A/Professor
principal investigator · National University of Singapore
Lily Song, Dr
principal investigator · The George Institute of Global Health, China
Craig Anderson, Professor
principal investigator · Executive Director The George Institute for Global Health - China

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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