Essential Acute Stroke Care in Low Resource Settings: a Pilot studY
EASY
1 other identifier
interventional
300
2 countries
4
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2025
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2019
CompletedFirst Posted
Study publicly available on registry
November 8, 2019
CompletedStudy Start
First participant enrolled
December 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2027
March 6, 2025
March 1, 2025
1.5 years
November 4, 2019
March 3, 2025
Conditions
Keywords
Outcome Measures
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.
30 days
Secondary Outcomes (1)
Death or disability
30 Days
Study Arms (2)
Usual Care
NO INTERVENTIONUsual care to be provided to patients as per hospital guidelines for 3 months
Intervention arm
OTHERThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The George Institutelead
- World Heart Federationcollaborator
Study Sites (4)
Murtala Muhammad Specialist Hospital
Kano, Kano State, 3200, Nigeria
Federal Medical Centre
Lokoja, Kogi State, 1001, Nigeria
Hospital de Apoyo II-2 Sullana
Piura, Peru
Hospital de la Amistad Peru Corea Santa Rosa II-2
Piura, Peru
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos Abanto, Dr
National Institute of Neurological Sciences, Lima, Peru
- PRINCIPAL INVESTIGATOR
Kolawawole Wahab, Professor
University of Ilorin & University of Ilorin Teaching Hospital Ilorin, Nigeria
- PRINCIPAL INVESTIGATOR
Hasan Farhan, Professor
President of Iraqi Scientific Council of Cardiology,Iraq
- PRINCIPAL INVESTIGATOR
Yi Sui, Dr
Shenyang First People's Hospital Hospital Affiliated Brain Hospital
- PRINCIPAL INVESTIGATOR
Saima Hilal, A/Professor
National University of Singapore
- PRINCIPAL INVESTIGATOR
Lily Song, Dr
The George Institute of Global Health, China
- PRINCIPAL INVESTIGATOR
Craig Anderson, Professor
Executive Director The George Institute for Global Health - China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The clinical outcome will be assessed by a blinded assessor
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2019
First Posted
November 8, 2019
Study Start
December 30, 2025
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
December 30, 2027
Last Updated
March 6, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data will be available after publication of the main paper
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.