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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Stroke
• Intervention / Treatment: Other: Acute stroke care Intervention arm

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cheryl Carcel, Dr; Phone Number: +61 2 8052 4508; Email: ccarcel@georgeinstitute.org.au
• Study Contact Backup: Name: Rebecca Anderson; Email: randerson@georgeinstitute.org.au

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	30 Days

Collaborators and Investigators

• Sponsor: The George Institute
• Collaborators: World Heart Federation
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Estimated): October 30, 2024
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: November 4, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (Actual): November 8, 2019

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Stroke; Ischemic stroke; hemorrhagic stroke; stroke package
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: GI_NM-01-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: Data will be available after publication of the main paper
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No