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NCT Number: NCT04157231

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

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Key information

Conditions

Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhagic Stroke Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Murtala Muhammad Specialist Hospital, Kano, Kano State, Nigeria

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acute stroke care Intervention arm

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Death or disability

    Time frame: 30 Days

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Cheryl Carcel, Dr

CONTACT

[email protected]

+61 2 8052 4508

Rebecca Anderson

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

The George Institute

Other

Collaborators

  • World Heart Federation

Registry information

Acronym: EASY

Important dates

Study start
2027
Primary completion
2030
Study completion
2030
First posted
Nov 8, 2019
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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