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

The George Institute

Status: Not yet enrolling

Conditions: Acute Stroke

Treatments: Other: Acute stroke care Intervention arm

Study type: Interventional

Funder types: Other

Identifiers

NCT04157231

GI_NM-01-2019

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Usual Care

No Intervention group

Description:

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

Intervention arm

Other group

Description:

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.

Treatment:

Other: Acute stroke care Intervention arm