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

Acute Stroke Clinical Trial

— EASY  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04157231
• Other study ID #: GI_NM-01-2019
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 30, 2024
• Est. completion date: November 30, 2025

Study information

• Verified date: August 2023
• Source: The George Institute
• Contact: Cheryl Carcel, Dr
• Phone: +61 2 8052 4508
• Email: ccarcel[@]georgeinstitute.org.au
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: November 30, 2025
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

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.

Locations

Country	Name	City	State
Nigeria	Murtala Muhammad Specialist Hospital	Kano	Kano State
Nigeria	Federal Medical Centre	Lokoja	Kogi State
Peru	Hospital de Apoyo II-2 Sullana	Piura
Peru	Hospital de la Amistad Peru Corea Santa Rosa II-2	Piura

Sponsors (2)

Lead Sponsor	Collaborator
The George Institute	World Heart Federation

Countries where clinical trial is conducted

Nigeria,  Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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