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

ConditionAcute Stroke

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorThe George Institute

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Sequential

Treatments tested in this trial

Acute stroke care Intervention arm
Other intervention
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.

Treatment groups

300 Participants

are divided into 2 treatment groups

Group A: Usual CareNo intervention 0 interventions

Group B: Intervention armOther 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

30 days

Secondary outcomes

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).

Time frame

30 Days

Sponsors and contacts

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The George Institute

Lead sponsor

World Heart Federation

Collaborator

Source ClinicalTrials.gov

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